TINA-QUANT IGA GEN.2
Received May 13, 2026 · Event occurred Apr 9, 2026
Report 1823260-2026-01891 · MDR key 25161151
Device
Product problems
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6) . THE FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTATIVE MAINTENANCE, DECONTAMINATION, AND PRECISION, MECHANICAL, AND OPERATIONAL CHECKS SUCCESSFULLY. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT IGA GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 353.0 MG/DL. THE CUSTOMER QUESTIONED THE RESULT AS IT WAS ACCOMPANIED BY A FLAG IN THEIR LABORATORY INFORMATION SYSTEM WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE RESULT WAS 271 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.