TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Mar 7, 2024 · Event occurred Feb 6, 2024
Report 1823260-2024-00686 · MDR key 18854834
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
71506001
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
THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 7%. THE REPEAT RESULT WAS 6%. THE REPEAT RESULT WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS PRO C 503 ANALYTICAL UNIT IS (B)(6). THE CUSTOMER STATED THAT THE ISSUE HAS BEEN RESOLVED WITH NEW CALIBRATIONS OF A NEW REAGENT LOT. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE CUSTOMER'S ACTION (REAGENT REPLACEMENT OF NEW LOT AND CALIBRATION) RESOLVED THE ISSUE.