TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Dec 15, 2023 · Event occurred Dec 1, 2023
Report 1823260-2023-04044 · MDR key 18336239
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08445699190
Lot number
ASKU
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C503 IS (B)(6). THE SERIAL NUMBER OF THE C303 ANALYZER IS (B)(6). A NEW LOT CALIBRATION WAS PERFORMED ON ONE OF THE INSTRUMENTS AND THE CONTROL RECOVERY IMPROVED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ONGOING ISSUES WITH PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PRO C 503 ANALYTICAL UNIT AND A COBAS PURE C 303 ANALYTICAL UNIT. THE C503 INSTRUMENT GENERALLY MEASURED HBA1C VALUES THAT WERE AROUND 1 % HIGHER THAN OTHER HOSPITALS, PARTICULARLY FOR HIGHER VALUES. THE CUSTOMER TESTED ONE PATIENT SAMPLE FOR HBA1C ON THE C503 AND C303 INSTRUMENTS. THE C503 HBA1C RESULT WAS 7.74 % AND THE C303 RESULT WAS 7.08 %. THE CUSTOMER STATED THAT THE ACTUAL VALUE BASED ON CLINICAL SYMPTOMS SHOULD BE ABOUT 7.3 %.