TINA-QUANT HBALC GEN. 3
Received Jul 14, 2023 · Event occurred Jun 15, 2023
Report 1823260-2023-02262 · MDR key 17329544
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsModel number
HBA1C TQ G3Catalog number
05336163190
Lot number
698229-01
Product problems
- High Test Results
- High Test Results
Patient
67 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS FOUND THAT THE CUSTOMER HAD NOT PERFORMED CALIBRATION IN THE RECOMMENDED INTERVAL PRIOR TO OBTAINING THE INITIAL RESULT. CALIBRATION HAD BEEN PREVIOUSLY PERFORMED ON (B)(6) 2023. PER PRODUCT LABELING, "HB AND HBA1C: FULL CALIBRATION IS RECOMMENDED - AFTER 29 DAYS DURING SHELF LIFE." THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 SERIES SYSTEM COBAS 6000 CORE UNIT. THE INITIAL HEMOGLOBIN A1C (HBA1C) RESULT WAS 6.2% WITH A DATA FLAG. THE CUSTOMER RE-CALIBRATED THE ASSAY AND REPEATED THE SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 5.7%. THE SAMPLE WAS SENT FOR HIGH PRESSURE LIQUID CHROMATOGRAPHY (HPLC) AND THE RESULT WAS 5.1%.