FDA Adverse Event
Malfunction
Summary report: N
ELECSYS TROPONIN T HS
MDR report key: 21751942
·
Received April 2, 2025
Report
- Report Number
- 1823260-2025-00979
- Event Type
- Malfunction
- Date Received
- April 2, 2025
- Date of Event
- March 12, 2025
- Report Date
- May 7, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- MMI
- PMA / PMN Number
- K201441
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT, AS QC WAS PASSING BEFORE THE EVENT.
Additional Manufacturer Narrative · 0
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS TROPONIN T HS RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 33.6 NG/L, AND THE REPEAT RESULT WAS 3.23 NG/L. TWO ADDITIONAL SAMPLES WERE COLLECTED, AND THEIR RESULTS WERE 3.50 NG/L AND 4.31 NG/L.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2323887 | ELECSYS TROPONIN T HS | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | MMI | ROCHE DIAGNOSTICS | 81184801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |