MalfunctionCFR
GLUCOSE HK
Received Jul 1, 2026 · Event occurred Jun 11, 2026
Report 1823260-2026-02639 · MDR key 25677000
Device
Generic name
Hexokinase, Glucose
Manufacturer
Roche DiagnosticsCatalog number
04657527190
Lot number
94209701
Product problems
- Non Reproducible Results
Patient
36 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C 111 ANALYZER IS (B)(4). CALIBRATION AND CONTROLS WERE ACCEPTABLE. A GENERAL REAGENT ISSUE CAN BE RULED OUT. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GLUCOSE HK ON A COBAS C 111 ANALYZER. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 208.84 MG/DL AND IT REPEATED AS 107.23 MG/DL.