TINA-QUANT IGA GEN.2
Received Dec 4, 2024 · Event occurred Nov 14, 2024
Report 1823260-2024-03514 · MDR key 20843740
Device
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
12 MO · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ALL RESULTS WERE ACCOMPANIED BY DATA FLAGS SINCE SYSTEM REAGENTS ON BOARD THE ANALYZER WERE EXPIRED. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO A USER ERROR SINCE SYSTEM REAGENTS EXCEEDED ONBOARD STABILITY AT THE TIME OF THE EVENT.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT IGA GEN.2 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN IGA VALUE OF 2.0 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 29.04 MG/DL.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C 303 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.