TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Nov 8, 2024 · Event occurred Oct 16, 2024
Report 1823260-2024-03242 · MDR key 20641397
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08445699190
Lot number
733772
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 INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION.
Additional Manufacturer Narrative
THE COBAS PURE C 303 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). NUMEROUS "ABNORMAL ASPIRATION" AND "SAMPLE SHORT" ERRORS WERE PRESENT IN THE ANALYZER ALARM TRACE. THIS MAY INDICATE POOR SAMPLE QUALITY AND A PREANALYTIC ISSUE AT THE CUSTOMER SITE. 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 PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.46 %. THE REPEAT RESULT ON THE SAME ANALYZER WAS 6.03 %. THE REPEAT RESULT USING A COBAS C311 ANALYZER AND REAGENT LOT 765161 WAS 5.3 %. THIS RESULT WAS BELIEVED TO BE CORRECT.