COBAS® GLU TEST STRIPS
Received May 27, 2026 · Event occurred May 6, 2026
Report 1823260-2026-02088 · MDR key 25303642
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582170
Lot number
873843
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS® GLU TEST STRIP LOT NUMBER WAS 873843 WITH AN EXPIRATION DATE OF 16-MAR-2027. THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. ALL RELEVANT INSPECTIONS FOR THE AFFECTED LOT OF COBAS GLU TEST STRIPS PASSED THE RELEASE REQUIREMENTS, CONFIRMING THE QUALITY OF THE LOT AT RELEASE.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW GLUCOSE RESULT FOR 1 NEONATE PATIENT SAMPLE TESTED ON A COBAS® PULSE METER. THE RESULT FROM A HEEL STICK ON THE PULSE METER WAS 2.2 MMOL/L. FOR CONFIRMATION, THE PATIENT WAS TESTED ON AN ACCU-CHEK INSTANT METER WITH RESULTS OF 3.1 MMOL/L AND 3.4 MMOL/L. THE SPECIFIC TIMEFRAME BETWEEN TESTS WAS NOT PROVIDED.