TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Nov 20, 2023 · Event occurred Oct 28, 2023
Report 1823260-2023-03688 · MDR key 18172801
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
07559674190
Lot number
66519701
Product problems
- High Test Results
- Output Problem
- High Test Results
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CUVETTE CELL SEGMENT WAS NOT ADJUSTED PROPERLY WHICH AFFECTED PIPETTING, WASHING, AND MIXING FUNCTIONS. THE CLOSED TUBE SAMPLING (CTS) PROBE WAS REPLACED. CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A MAINTENANCE ISSUE.
Additional Manufacturer Narrative
THE C513 ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 (A1CX3) ON A COBAS C 513 ANALYZER. THE INITIAL RESULT WAS 14.2%. THE REPEAT RESULT WAS 6.3%. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.