TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Sep 18, 2023 · Event occurred Jul 7, 2023
Report 1823260-2023-02997 · MDR key 17763587
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
698253
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE HBA1C RESULTS FROM ABOUT 7 TO 10 PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED TO THE PATIENTS. THE REPORTER STATED THAT THE RESULTS OF THE 7-10 SAMPLES WERE HIGH - BETWEEN 8-10%. THE REPORTER STATED THAT THE PATIENTS ALLEGED THAT THEY HAVE A NON-DIABETIC HISTORY AND THAT THEY RETESTED BY THEMSELVES AT OTHER SITES AND THE RESULTS WERE NORMAL.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS PRO C 503 ANALYTICAL UNIT IS (B)(6) . THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION REVIEWED THE ALARM TRACE. THERE WERE FREQUENT "ABNORMAL ASPIRATION" ALARMS AND MULTIPLE "STD.E", "SAMP.S" CALIBRATION FAILURES. THESE ALARMS POINT TO MAINTENANCE/HARDWARE PERFORMANCE ISSUES. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.