TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Nov 17, 2023 · Event occurred Oct 26, 2023
Report 1823260-2023-03646 · MDR key 18158758
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
715056
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
THE ISSUE WAS RESOLVED AFTER THE EXCHANGE AND ADJUSTMENT OF A SAMPLE PROBE. NO FURTHER ISSUES HAVE OCCURRED. THE INVESTIGATION DETERMINED THE EXCHANGE AND ADJUSTMENT OF THE PROBE RESOLVED THE ISSUE.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). THE SAMPLE PROBE ASSEMBLY WAS CHANGED AND ADJUSTED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 (HBA1C) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.81 % AND IT REPEATED AS 5.45 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.34 % AND IT REPEATED AS 5.77 %. THE THIRD SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.95 % AND IT REPEATED AS 5.40 %.