COBAS® GLU TEST STRIPS
Received Feb 17, 2026 · Event occurred Jan 24, 2026
Report 1823260-2026-00557 · MDR key 24369268
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582170
Lot number
831845
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE LOW GLUCOSE RESULTS NOT CORRESPONDING TO THE CLINICAL STATUS FOR 1 PATIENT TESTED ON 2 COBAS® PULSE METERS WITH SERIAL NUMBERS (B)(6) (METER A) AND (B)(6) (METER B). THE RESULT AT 7:47 A.M. ON METER B WAS 1.6 MMOL/L. THE RESULT AT 4:34 P.M. ON METER B WAS 4.7 MMOL/L. ON (B)(6) 2026, THE RESULT AT 7:48 A.M. ON METER A WAS 1.5 MMOL/L. THE RESULT AT 7:50 A.M. ON METER A WAS 4.3 MMOL/L. THE PATIENT HAD NO HYPOGLYCEMIC SYMPTOMS AT THE TIME OF THE LOW RESULTS. FOR VERIFICATION, THE PATIENT WAS ALSO TESTED ON AN ACCU-CHEK INSTANT METER WITH A RESULT OF 6 MMOL/L. THE HIGHER RESULTS WERE BELIEVED TO BE CORRECT. THE SAME TEST STRIP LOT NUMBER WAS USED ON BOTH PULSE METERS.
Additional Manufacturer Narrative
THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION.