TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Dec 20, 2024 · Event occurred Nov 29, 2024
Report 1823260-2024-03776 · MDR key 20992750
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08445699190
Lot number
801607
Product problems
- High Test Results
- Output Problem
- High Test Results
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DUE TO THE LACK OF ADDITIONAL INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON THE ABNORMAL ASPIRATION ERRORS, THE EVENT WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE WAS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.
Additional Manufacturer Narrative
THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INTIMAL RESULT WAS 16.3% AND THE REPEAT RESULTS WERE 5.33% AND 5.36%.