TINA-QUANT HEMOGLOBIN A1CDX GEN. 3
Received Sep 25, 2023 · Event occurred Sep 1, 2023
Report 1823260-2023-03085 · MDR key 17808529
Device
Generic name
Glycosylated Hemoglobin Assay
Manufacturer
Roche DiagnosticsCatalog number
08056668190
Lot number
698253
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- 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 ALARM TRACE SHOWED FREQUENT ABNORMAL ASPIRATION ALARMS. THIS COULD INDICATE A CONTAMINATION OF THE PROBE. A PHOTO OF THE PROBE SHOWED CONTAMINATION. THE INVESTIGATION DETERMINED THE ACTION OF ADJUSTING THE WASH STATION RESOLVED THE ISSUE.
Additional Manufacturer Narrative
IT WAS OBSERVED THAT THE SAMPLE PROBE WAS COVERED IN GEL. THE MIXER ADJUSTMENT WAS CHECKED AND IT WAS OK. PROBES WERE CHANGED AND ADJUSTED. PRECISION STUDIES WERE PERFORMED BUT WERE NOT ACCEPTABLE. THE RINSE STATION WAS CLEANED AND IT WAS DETERMINED THAT IT NEEDED ADJUSTING. THE WASH STATION WAS ADJUSTED AND AFTER THIS, RECOVERY WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PRO C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C RESULT OF 8.4 %. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HBA1C VALUE OF 5.5 %. THE FIRST SAMPLE WAS THEN REPEATED ON (B)(6) 2023, RESULTING IN A VALUE OF 5.5 %. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 9.53 % AND IT REPEATED AS 7.34 %. THE THIRD PATIENT SAMPLE RESULTED IN THE FOLLOWING HBA1C VALUES ON (B)(6) 2023: 6.39 %, 9.36 %, 7.34 %, 8.19 %, 7.19 %, 6.95 %, 8.64 %, 12.5 %, 9.94 %, 12.2 %, AND 7.05 %.