COBAS® GLU TEST STRIPS
Received Mar 28, 2025 · Event occurred Mar 5, 2025
Report 1823260-2025-00922 · MDR key 21718466
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582172
Lot number
772789
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Human-Device Interface Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Human-Device Interface Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS PULSE INSTRUMENT'S SERIAL NUMBER WAS (B)(6). THE QUALITY CONTROL RESULTS FOR THE DEVICE ON THE DATE OF THE EVENT WERE ACCEPTABLE. THE METER AND STRIPS HAVE BEEN REQUESTED FOR RETURN. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS USING THE COBAS® GLU TEST STRIPS WITH A COBAS PULSE INSTRUMENT. THE RESULT AT 16:09 WAS 524 MG/DL. THE RESULT AT 16:13 WAS 308 MG/DL. THE RESULT AT 22:41 WAS 361 MG/DL. THE NURSE BELIEVED THIS RESULT WAS INACCURATE THE RESULT AT 22:43 WAS 142 MG/DL. AFTER THIS RESULT, THE PATENT WAS GIVEN AN INSULIN INJECTION. THE MEASUREMENTS WERE TAKEN FROM THE PATIENT'S FINGERTIP BUT FROM DIFFERENT FINGERS.
Additional Manufacturer Narrative
AS NO PRODUCT WAS RETURNED, FURTHER INVESTIGATION WAS NOT POSSIBLE. RELEVANT RETENTION MATERIAL WAS TESTED AND PERFORMED WITHIN SPECIFICATIONS. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.