GLUCOSE HK GEN.3
Received Jun 26, 2026 · Event occurred Jun 2, 2026
Report 1823260-2026-02549 · MDR key 25636143
Device
Generic name
Glucose Hexokinase
Manufacturer
Roche DiagnosticsCatalog number
08057800190
Lot number
936947
Product problems
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLY LOW GLUCOSE HK GEN.3 ASSAY RESULTS FOR 3 SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS C 503 ANALYTICAL UNIT. ON (B)(6) 2026: THE RESULT FROM THE ANALYZER WAS 6 MG/DL. THE RESULT FROM A GLUCOMETER USING ANOTHER SAMPLE COLLECTED LATER WAS NORMAL AND WITHIN THE METER'S RANGE. ON (B)(6) 2026: THE RESULT FROM THE ANALYZER WAS 2 MG/DL. THIS RESULT WAS PROVEN TO BE REPEATABLE. THE CAPILLARY GLUCOMETER RESULTS CHECKED ON THE SAME DAY RANGED FROM 89 TO 106 MG/DL. ON (B)(6) 2026: THE RESULT FROM THE ANALYZER WAS <2 MG/DL. THIS RESULT WAS PROVEN TO BE REPEATABLE. THE CONCURRENT CAPILLARY GLUCOMETER READINGS REMAINED WITHIN THE 89-106 MG/DL RANGE. THE PHYSICIAN QUESTIONED THE ANALYZER RESULTS, AS THEY WERE DEEMED INCOMPATIBLE WITH LIFE.