TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Jun 24, 2024 · Event occurred May 21, 2024
Report 1823260-2024-01847 · MDR key 19601016
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
765168
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 C 303 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 4.42 %. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 6.61 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 4.68 % ON (B)(6) 2024. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 7.28 % ON (B)(6) 2024.