TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Sep 18, 2023 · Event occurred Aug 23, 2023
Report 1823260-2023-03008 · MDR key 17766033
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
07559674190
Lot number
67251001
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) MADE REAGENT AND SAMPLE PROBE ADJUSTMENTS. THE CUVETTE SEGMENTS WERE SEATED PROPERLY. THE SAMPLE PROBE WAS CHECKED FOR OBSTRUCTIONS BY FLUSHING. THE FSE NOTED THAT THE REAGENT PACKS MAY HAVE FROZEN IN THE CUSTOMER'S REFRIGERATOR. THE CUSTOMER HAS NOT COMPLAINED OF ANY FURTHER ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE C513 ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE REPRESENTATIVE (FSR) CHECKED CALIBRATION, QC, AND OPERATOR MAINTENANCE AND DID NOT IDENTIFY ANY ISSUES. INSTRUMENT PERFORMANCE TESTING WAS ACCEPTABLE. FREQUENT ABNORMAL ASPIRATION ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C513 ANALYZER. PATIENT 1 INITIAL RESULT WAS 7.41% ON (B)(6) 2023 THE SAMPLE WAS REPEATED ON A COBAS 8000 C 502 MODULE WITH A RESULT OF 5.86%. PATIENT 2 INITIAL RESULT WAS 11.03%. ON (B)(6) 2023 THE SAMPLE WAS REPEATED ON A COBAS 8000 C 502 MODULE WITH A RESULT OF 9.51%.