ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
Received Feb 15, 2024 · Event occurred Jan 18, 2024
Report 1823260-2024-00452 · MDR key 18712682
Device
Generic name
Igm (mu Chain Specific) Test
Manufacturer
Roche DiagnosticsModel number
NACatalog number
08057923190
Lot number
716688
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION WAS LAST PERFORMED ON (B)(6) 2024. THE ALARM TRACE SHOWED SAMPLE FOAM, SAMPLE CLOT, SAMPLE PROBE, AND ABNORMAL ASPIRATION ERRORS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6) . THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE ANALYZER IS OPERATING PROPERLY. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE IGM-2 TINA-QUANT IGM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL IGM RESULT WAS 43 MG/DL. THE CUSTOMER WAS HAVING ISSUES WITH PROFICIENCY SAMPLES WHICH PROMPTED THEM TO RERUN QC AND CALIBRATION, AS WELL AS PERFORM A PATIENT SAMPLE COMPARISON. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 31.3 MG/DL.
Additional Manufacturer Narrative
THE MEDICAL CODING FOR THIS CASE WAS UPDATED.