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What This Guide Helps With
Unexpected glucose results caused by sample differences, strip problems, contamination, test conditions, comparison timing, meter performance, or QC failure.
Step-by-Step Troubleshooting
1. Protect Patient Care and Treat the Result as Unverified
If a glucose result is inconsistent with the patient's condition or another measurement, clinical staff should obtain confirmation using another approved method before making decisions based solely on the questionable result.
Do not troubleshoot the meter while it is being relied upon for active patient management.
Expected outcome: Patient care proceeds using a verified result while the suspect meter is evaluated.
2. Clarify the Comparison
Determine what the StatStrip result was compared against: another bedside meter, laboratory analyzer, blood gas analyzer, or repeat specimen.
Record whether both samples were collected at approximately the same time and from comparable specimen sources.
Expected outcome: The comparison is understood well enough to determine whether the values can reasonably be evaluated together.
3. Inspect the Strip and Test Materials
Verify the correct strip type, acceptable storage, clean handling, and absence of visible damage or contamination.
Replace questionable strips with a known-good supply.
Expected outcome: Strip condition is ruled out as an obvious source of inconsistent results.
If consistent results return with known-good strips and control testing passes, troubleshooting can stop.
4. Inspect the Meter for Contamination or Damage
Check the strip port, housing, and surrounding surfaces for blood, liquid, cleaning residue, corrosion, cracks, or evidence of liquid intrusion.
Do not perform deep disassembly or internal cleaning.
Expected outcome: No visible condition exists that could interfere with strip connection or testing.
5. Perform Approved Quality-Control Testing
Run the facility-approved QC materials according to established procedure.
Do not adjust calibration or configuration merely to make the meter agree with another device.
Expected outcome: QC results are acceptable according to the approved system criteria.
If QC fails, remove the meter from clinical use until the cause is identified.
6. Compare With a Known-Good StatStrip
Using the same approved control material, compare the suspect meter to another verified StatStrip when available.
This avoids drawing conclusions from patient samples that may differ because of collection timing or specimen characteristics.
Expected outcome: The suspect meter performs consistently with another verified meter during controlled testing.
7. Review Sample Collection Factors
Confirm with clinical staff whether the discrepant result could have involved contamination, inadequate specimen collection, delayed testing, an unusual sample source, or another collection variable.
Clinical Engineering should not diagnose the patient or interpret clinical significance.
Expected outcome: Collection-related causes are either identified or reasonably excluded.
8. Check Date, Time, and Identification
Verify that the result being compared belongs to the correct patient, operator, meter, date, and time.
A mismatch in patient association or result timestamp can appear to be a measurement discrepancy.
Expected outcome: Both values being compared are confirmed to refer to the intended patient and testing period.
9. Perform Final Verification
Run repeat approved controls or other manufacturer-authorized functional verification after correcting any identified external cause.
Expected outcome: The meter produces repeatable, acceptable results under controlled conditions.
If successful, troubleshooting may stop and the meter may be returned to service according to facility policy.
10. Escalate Persistent Measurement Discrepancies
If known-good strips, proper QC, appropriate collection conditions, and controlled comparison testing still show unreliable meter performance, remove the device from service.
Expected outcome: A potentially inaccurate meter is kept out of clinical use.
If the Problem Persists
External causes such as strip condition, sample handling, contamination, identification errors, and comparison timing have been evaluated. Remaining possibilities include a service-level measurement-system problem, strip-interface failure, configuration issue, or other internal fault.
The meter should be:
- Removed from service.
- Labeled Out of Service.
- Sent for repair or bench evaluation.
- Evaluated using appropriate Nova Biomedical documentation and approved test equipment.
- Repaired or configured only by qualified personnel.
- Fully verified with approved testing before return to service.
Stopping when accuracy cannot be demonstrated is proper troubleshooting.
Clinical Use Tip
An unexpected bedside glucose value should be clinically confirmed rather than explained away as a meter problem without controlled verification.
Work Order Documentation (CCR Method)
CCR = Complaint, Cause, Resolution
Complaint
What was reported by the clinical staff.
Example:
"Nursing reported that the StatStrip produced glucose results that differed significantly from repeated bedside measurements."
Cause
What was observed during troubleshooting.
Example:
"Clinical Engineering found that the suspect meter passed QC, but the reported comparison involved different specimen times and a questionable strip container."
Resolution
What action was taken.
Example:
"The questionable strips were removed from use, the meter passed repeated QC with known-good strips, and the unit was returned to service after verification."
Helpful Details to Include (If Known)
- Reported StatStrip result
- Comparison result and method
- Time between specimens
- Specimen source
- Strip lot or container
- QC results
- Known-good meter comparison
- Strip-port condition
- Patient and operator identification
- Final verification results
Final Thought
Protect the patient, compare measurements under controlled conditions, verify strips and QC before assuming internal failure, and remove the meter from service whenever reliable measurement cannot be demonstrated.
That is successful troubleshooting.