COBAS® GLU TEST STRIPS
Received Jun 10, 2026 · Event occurred May 11, 2026
Report 1823260-2026-02279 · MDR key 25456028
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Roche DiagnosticsCatalog number
09009582172
Lot number
87384303
Product problems
- Imprecision
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR 1 PATIENT USING THE COBAS® GLU TEST STRIPS USING A COBAS® PULSE. THE INITIAL RESULT AT 12:02 WAS 241 MG/DL, AND THE PATIENT WAS TREATED WITH 4 UNITS OF NOVORAPID. AT 17:13, THE PATIENT'S RESULT WAS 51 MG/DL. THE CUSTOMER QUESTIONED THIS RESULT AND CHECKED IT AGAIN USING A DIFFERENT METHOD. THE RESULT FROM AN ACCU-CHEK METER WAS 300 MG/DL. AT 17:21, THE PATIENT'S RESULT WAS 277 MG/DL. THE CUSTOMER REPORTED THAT THERE WERE NO ADVERSE SYMPTOMS OR INTERVENTION GIVEN WHEN THE GLUCOSE DROPPED.
Additional Manufacturer Narrative
THE COBAS® PULSE SERIAL NUMBER IS (B)(6). THE MATERIAL HAS BEEN REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.