TINA-QUANT HBALC GEN. 3
Received Nov 29, 2022 · Event occurred Nov 10, 2022
Report 1823260-2022-03790 · MDR key 15880427
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsModel number
HBA1C TQ G3Catalog number
ASKU
Lot number
625162
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CHANGED THE REAGENT AND NO FURTHER ISSUES OCCURRED AFTER THIS. CALIBRATION DATA SHOWED FREQUENT CALIBRATION ERRORS AND SHORT SAMPLES. QUALITY CONTROL DATA SHOWED A VALUE THAT WAS OUTSIDE OF RANGE. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 ON A COBAS 6000 C (501) MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 8.5 %. THE SAMPLE WAS REPEATED ON (B)(6) 2022, RESULTING IN A VALUE OF 12.4 %. THE REPEAT VALUE WAS BELIEVED TO BE CORRECT. THE SERIAL NUMBER OF THE C 501 ANALYZER IS (B)(4).