TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Aug 15, 2024 · Event occurred Jul 23, 2024
Report 1823260-2024-02372 · MDR key 19990349
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
07559674190
Lot number
765185
Product problems
- High Test Results
- High Readings
- High Test Results
- High Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS C513 ANALYZER COMMERCIAL SYSTEM SERIAL NUMBER WAS (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 C513 ANALYZER COMMERCIAL SYSTEM. THE INITIAL RESULT WAS 10.0%. ON (B)(6) 2024, THE REPEAT RESULT ON THE SAME ANALYZER WAS 6.3%, AND ON A DIFFERENT ANALYZER WAS 6.3%. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WAS AMENDED WITH THE REPEAT RESULT.
Additional Manufacturer Narrative
DUE TO THE INSUFFICIENT INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.