TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Mar 28, 2024 · Event occurred Mar 11, 2024
Report 1823260-2024-00930 · MDR key 18997223
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
718886
Product problems
- Incorrect Measurement
- High Test Results
- Non Reproducible Results
- Incorrect Measurement
- High Test Results
- Non Reproducible Results
Patient
28 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT A REAGENT RELATED ISSUE CAN BE EXCLUDED. UPON ANALYSIS OF THE ANALYZER DATA FILES, THE SYSTEM WAS FOUND TO BE WORKING WITHIN SPECIFICATIONS. THE ALARM TRACE SHOWED MULTIPLE ABNORMAL ASPIRATION ALARMS. THESE ALARMS INDICATE AN ISSUE WITH SAMPLE QUALITY. THE CUSTOMER IMPROVED THEIR CENTRIFUGATION SPEED AND CONFIRMED THERE WERE NO FURTHER ISSUES. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C503 ANALYZER IS (B)(6) . QUALITY CONTROL DATA WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.1 %. THE PATIENT ASKED FOR A REPEAT OF THE SAMPLE. THE SAMPLE WAS REPEATED, RESULTING IN AN HBA1C VALUE OF 5.78 %.