TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION
Received Jul 3, 2025 · Event occurred Jun 17, 2025
Report 1823260-2025-02040 · MDR key 22393792
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
774553
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 4000 C311 STAND ALONE SYSTEM SERIAL NUMBER WAS (B)(6). 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 FROM THE COBAS 4000 C311 STAND-ALONE SYSTEM. THE INITIAL RESULT WAS 6.2 % AND THE REPEAT RESULT FROM A BIO-RAD D10 ANALYZER WAS 10.8%.
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.