COBAS® GLU TEST STRIPS
Received Jun 17, 2026 · Event occurred May 22, 2026
Report 1823260-2026-02410 · MDR key 25536268
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582243
Lot number
873843
Product problems
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR 1 PATIENT SAMPLE USING THE COBAS GLU TEST STRIPS ON A COBAS® PULSE INSTRUMENT. THE PATIENT'S HISTORY OF RESULTS WAS PROVIDED FOR (B)(6) 2026 THROUGH (B)(6) 2026. THERE WAS 1 EXAMPLE OF DISCREPANT RESULTS FROM (B)(6) 2026. THE INITIAL GLUCOSE RESULT WAS 182 MG/DL AT 1:09. THE RESULT ON ANOTHER COBAS PULSE DEVICE AT 1:09 WAS 127 MG/DL. THE SECOND RESULT FROM THE OTHER COBAS PULSE DEVICE WAS DEEMED TO BE CORRECT.
Additional Manufacturer Narrative
THE COBAS GLU TEST STRIPS LOT NUMBER WAS 873843, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.