TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Dec 23, 2024 · Event occurred Dec 5, 2024
Report 1823260-2024-03801 · MDR key 21004197
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
ASKU
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 10.5 % AND IT REPEATED AS 5.8 %.
Additional Manufacturer Narrative
THE INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, AND COMPONENT CODES HAVE BEEN UPDATED.
Additional Manufacturer Narrative
THE CELL WASH WAS NOT OPTIMAL AND IT WAS IMPROVED AFTER ADJUSTMENTS PERFORMED BY THE FIELD SERVICE ENGINEER. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH WATER DROPS IN THE REACTION CELLS. THE ROOT CAUSE OF WATER DROPLETS IN THE CELLS COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
A HARDWARE CHECK INDICATED THERE WERE ISSUES WITH THE CELL RINSE ON THE ANALYZER. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH AN ISSUE WITH CELL RINSE HARDWARE ADJUSTMENTS. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES.