TINA-QUANT HEMOGLOBIN A1CDX GEN.3
Received May 13, 2025 · Event occurred Apr 26, 2025
Report 1823260-2025-01469 · MDR key 22008423
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
793043
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 A1CDX GEN.3 RESULT FROM THE COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.46%, AND THE REPEAT RESULT WAS 5.81%. THE REPEAT RESULT WAS DEEMED TO BE CORRECT BECAUSE IT MATCHED THE PATIENT'S HISTORY.
Additional Manufacturer Narrative
THE COBAS C 303 ANALYTICAL UNIT SERIAL NUMBER (B)(6). THE QC SHOWED STRONG IMPRECISION, AND THE ALARM TRACE INDICATED AN ISSUE WITH THE SAMPLE PROBE. A FIELD SERVICE ENGINEER (FSE) REPLACED THE GEAR PUMP HEAD, REACTION CELLS AND THE HALOGEN LAMP. CALIBRATION AND QC WERE COMPLETED. A HARDWARE PRECISION AND PRECISION RUNS WERE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE, AS MANY ACTIONS WERE PERFORMED.