TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION
Received Jul 1, 2026 · Event occurred Jun 8, 2026
Report 1823260-2026-02633 · MDR key 25676856
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
92402801
Product problems
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 4000 C311 STAND-ALONE SYSTEM SERIAL NUMBER IS (B)(6). A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE GEAR PUMP PRESSURE WAS OKAY, THE SAMPLE AND REAGENT PROBE ADJUSTMENTS WERE OKAY, AND THERE WERE NO ISSUES OBSERVED WITH THEM. THE FSE VERIFIED THAT THE RINSE MECHANISM WAS OKAY AND REPLACED THE VACUUM PUMP DIAPHRAGM. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE PATIENT'S INITIAL HBA1C RESULT WAS 6.7%, ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT RESULT WAS 5.9%, ACCOMPANIED BY A DATA FLAG. THE SECOND REPEAT RESULT WAS 5.7%. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WERE ALSO QUESTIONABLE RESULTS REPORTED FOR CALCIUM GEN.2 ASSAY. THIS MEDWATCH WILL APPLY TO THE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ASSAY. PLEASE REFER TO: MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE CALCIUM GEN.2 ASSAY.