TINA-QUANT HEMOGLOBIN A1CDX GEN.3
Received Dec 3, 2025 · Event occurred Nov 8, 2025
Report 1823260-2025-04927 · MDR key 23706716
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
872465
Product problems
- High Test Results
- High Test Results
Patient
32 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). QC INFORMATION WAS NOT PROVIDED. CALIBRATION DATA WAS REVIEWED AND FOUND TO BE WITHIN RANGE DURING THE EVENT. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE EVENT WAS A SINGLE INCIDENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE DUE TO A LACK OF INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE OF A REAGENT ISSUE. IT IS CONFIRMED THAT THE INSTRUMENT IS WORKING WITHIN SPECIFICATIONS.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 6.3%, AND THE REPEAT RESULT WAS REPORTED TO BE NORMAL. THE EXACT RESULT WAS NOT PROVIDED. THE PATIENT COMPLAINED ABOUT THE INITIAL RESULT AND WENT TO ANOTHER LABORATORY. THE NEW SAMPLE RESULT WAS 5.1%.