COBAS® GLU TEST STRIPS
Received May 6, 2026 · Event occurred Apr 8, 2026
Report 1823260-2026-01778 · MDR key 25100050
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582170
Lot number
87384301
Product problems
- Non Reproducible Results
Patient
0 DA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION; HOWEVER, THERE ARE NO STRIPS REMAINING TO RETURN. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW GLUCOSE RESULT FOR A NEONATE PATIENT SAMPLE TESTED ON A COBAS® PULSE METER. THE HEEL STICK RESULT ON THE COBAS PULSE METER WAS 2.5 MMOL/L. THIS RESULT DID NOT CORRESPOND TO THE PATIENT¿S CONDITION. THE RESULT FROM THE SAME HEEL STICK ON AN ACCU-CHEK INSTANT METER WAS 4.1 MMOL/L. THE LOW RESULT FROM THE COBAS PULSE METER IS IN QUESTION.