MalfunctionPZI
COBAS® GLU TEST STRIPS
Received Jun 17, 2026 · Event occurred May 27, 2026
Report 1823260-2026-02415 · MDR key 25537215
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582170
Lot number
831845, 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® PULSE SERIAL NUMBERS ARE (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS USING THE COBAS® GLU TEST STRIPS FOR 3 PATIENT SAMPLES ON 2 COBAS® PULSE INSTRUMENTS. PLEASE SEE THE ATTACHMENT "(B)(6)" FOR THE RESULTS.