TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Nov 6, 2023 · Event occurred Sep 30, 2023
Report 1823260-2023-03520 · MDR key 18072463
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
70882001
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS PRO C 503 ANALYTICAL UNIT IS 2058-03. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 7.65 %. THE REPEAT RESULT WAS 5.58%. THE REPEAT RESULT WAS BELIEVED TO BE THE TRUE RESULT BASED ON THE PATIENT'S HISTORY AND THE GLUCOSE RESULT.