TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION
Received Apr 1, 2025 · Event occurred Feb 26, 2025
Report 1823260-2025-00971 · MDR key 21746002
Device
Generic name
Assay, Glycosylated Hemoglobin
Manufacturer
Roche DiagnosticsCatalog number
05336163190
Lot number
790123
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DATA WAS REQUESTED FOR FURTHER INVESTIGATION, BUT NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE PRODUCT MEETS THE SPECIFICATIONS.
Additional Manufacturer Narrative
THE C311 STAND ALONE SYSTEM SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE TINA-QUANT HBA1C GEN. 3RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE RESULT USING THE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) TECHNIQUE WAS 5.1. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE IN THE ANALYZER, AND THE RESULT WAS 7.3. THE UNIT OF MEASUREMENT WAS NOT PROVIDED.