TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION
Received May 5, 2025 · Event occurred Apr 9, 2025
Report 1823260-2025-01380 · MDR key 21960187
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
77732101
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULT FROM THE COBAS INTEGRA 400 PLUS W/O ISE ANALYZER. THE INITIAL RESULT WAS 6.95 %. THE REPEAT RESULT WAS 5.75 % AND WAS BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
THE COBAS INTEGRA 400 PLUS W/O ISE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND DID NOT FIND ANY ISSUES. THE INVESTIGATION IS ONGOING.
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.