TINA-QUANT HBALC GEN. 3
Received Nov 21, 2023 · Event occurred Nov 4, 2023
Report 1823260-2023-03722 · MDR key 18181936
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
629598
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE COBAS INTEGRA 400 PLUS ANALYZER IS (B)(6). 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 HBALC GEN. 3 ON A COBAS INTEGRA 400 PLUS. NO UNITS OF MEASURE WERE PROVIDED. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.3. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN AN HBA1C VALUE OF 5.6. THE SAMPLE WAS ALSO REPEATED ON THE COMPLAINED ANALYZER, RESULTING IN AN HBA1C VALUE OF 5.4.