COBAS® GLU TEST STRIPS
Received Jun 25, 2025 · Event occurred Jun 5, 2025
Report 1823260-2025-01952 · MDR key 22328605
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582172
Lot number
844228
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO MATERIALS WERE SENT BACK BY THE CUSTOMER. BLOOD SAMPLES FROM TWO DIFFERENT CONCENTRATIONS WERE MEASURED 10 TIMES FOR EACH CONCENTRATION ON COBAS PULSE REFERENCE INSTRUMENTS USING THE RETENTION COBAS PULSE GLU TEST STRIPS FROM THE LOT 844228. IN ADDITION, THE BLOOD SAMPLES WERE TESTED IN THE REFERENCE LABORATORY. NO ABNORMALITIES WERE FOUND DURING INVESTIGATION OF THE RETENTION MATERIAL. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. MEDWATCH FIELD H3 HAS BEEN UPDATED.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED A DISCREPANT GLUCOSE RESULT FOR ONE PATIENT TESTED WITH COBAS GLU TEST STRIPS ON COBAS PULSE INSTRUMENT SERIAL NUMBER (B)(6). AT 11:31, A SAMPLE FROM THE PATIENT WAS TESTED USING THE COBAS PULSE INSTRUMENT, RESULTING IN A GLUCOSE VALUE OF < 0.6 MMOL/L. AT 11:40, A SAMPLE FROM THE PATIENT WAS TESTED USING AN ACCU-CHEK INFORM II METER, RESULTING IN A GLUCOSE VALUE OF 8.4 MMOL/L.
Additional Manufacturer Narrative
THE TEST STRIPS WERE REQUESTED FOR INVESTIGATION. THEY HAVE NOT BEEN RECEIVED AT THIS TIME. THE INVESTIGATION IS ONGOING.