ELECSYS IL-6
Report
- Report Number
- 1823260-2023-02452
- Event Type
- Malfunction
- Date Received
- July 24, 2023
- Date of Event
- June 25, 2023
- Report Date
- August 31, 2023
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- QLC
- PMA / PMN Number
- EUA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : NA.
THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IL-6 RESULTS FOR 2 SAMPLES DRAWN FROM THE PATIENT AT THE SAME TIME AND RUN ON TWO COBAS 8000 - COBAS E 602 MODULES. ON (B)(6)2023, SAMPLE 1 HAD AN INITIAL RESULT OF 1.91 PG/ML ON ANALYZER SERIAL NUMBER (B)(6) IN THE LABORATORY REPORTING THE ISSUE. ON(B)(6)2023, THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND THE RESULT WAS 28.8 PG/ML. THE SAMPLE WAS ALSO REPEATED ON ANALYZER SERIAL NUMBER (B)(6) IN A DIFFERENT LABORATORY AND THE RESULT WAS 33.82 PG/ML. ON (B)(6)-2023, SAMPLE 2 HAD AN INITIAL RESULT OF 130.8 PG/ML ON ANALYZER SERIAL NUMBER (B)(6) IN THE OTHER LABORATORY. ON (B)(6)-2023, THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND THE RESULT WAS 180.6 PG/ML. THE SAMPLE WAS ALSO REPEATED ON THE ANALYZER SERIAL NUMBER (B)(6) IN THE REPORTING LABORATORY AND THE RESULT WAS 190.6 PG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 992632 | ELECSYS IL-6 | INTERLEUKIN 6 | QLC | ROCHE DIAGNOSTICS | IL-6 | 62092801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |