COBAS® GLU TEST STRIPS
Received Dec 10, 2025 · Event occurred Oct 31, 2025
Report 1823260-2025-05043 · MDR key 23769587
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582243
Lot number
861467
Product problems
- Incorrect Measurement
- Incorrect Measurement
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS® PULSE SERIAL NUMBERS ARE (B)(6). THE PRODUCT WAS REQUESTED FOR INVESTIGATION. ALL OF THE STRIPS WERE CONSUMED AND WILL NOT BE RETURNED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULT USING THE COBAS® GLU TEST STRIPS WITH TWO COBAS® PULSE DEVICES FOR ONE PATIENT. THE INITIAL RESULT AT 12:21 WAS 238 MG/DL, WITH SERIAL NUMBER (B)(6). ANOTHER RESULT AT 12:21 WAS 173 MG/DL, WITH SERIAL NUMBER (B)(6). A VENOUS SAMPLE WAS COLLECTED AND TESTED USING THE COBAS PRO AT 15:15, WITH A RESULT OF 165 MG/DL. NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE QUESTIONABLE RESULTS.