MalfunctionLCP
TINA-QUANT HBALC GEN. 3
Received Apr 30, 2024 · Event occurred Apr 13, 2024
Report 1823260-2024-01315 · MDR key 19213715
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS INTEGRA 400 PLUS WAS REQUESTED BUT NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS INTEGRA 400 PLUS. THE RESULT FROM THE ANALYZER WAS 13.44%. THE RESULT FROM THE OTHER LABORATORY WAS 6.70%.