A1C-3
Received Apr 1, 2022 · Event occurred Mar 4, 2022
Report 1823260-2022-00928 · MDR key 13975880
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsModel number
HBA1C TQ G3Catalog number
05336163190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 2 SAMPLES FROM 1 PATIENT TESTED FOR A1C-3 ON A COBAS 8000 C 502 MODULE. ON APPROXIMATELY (B)(6) 2022 THE RESULT FROM THE C502 MODULE WAS 31.8%. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS CONSIDERED TO BE NOT BELIEVABLE. THIS SAMPLE WAS REPEATED BY AN UNSPECIFIED CHROMATOGRAPHY METHOD AND THE RESULT WAS 17.8%. THIS RESULT WAS BELIEVED TO BE CORRECT. ON (B)(6) 2022 A 2ND SAMPLE WAS OBTAINED AND THE RESULT FROM THE C502 MODULE WAS 28.7%. SOMETIME DURING THE WEEK OF (B)(6) 2022 ANOTHER SAMPLE WAS OBTAINED FROM THE PATIENT AND THE RESULT FROM THE C502 MODULE WAS 17.1% WHICH CORRESPONDS TO THE RESULT FROM THE CHROMATOGRAPHY METHOD. ON (B)(6) 2022 THE CUSTOMER REPEATED ANOTHER SAMPLE FROM THE PATIENT ON THE C502 MODULE AND THE RESULT WAS 16.8% WHICH CORRESPONDS TO THE RESULT FROM THE CHROMATOGRAPHY METHOD. THE C502 MODULE SERIAL NUMBER WAS (B)(4).
Additional Manufacturer Narrative
NO FURTHER INFORMATION OR DATA WAS PROVIDED BY THE CUSTOMER. SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION BUT WAS NO LONGER AVAILABLE TO SEND. FROM THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.