FDA Adverse Event
Malfunction
Summary report: N
ELECSYS TROPONIN T HS
MDR report key: 24788703
·
Received April 6, 2026
Report
- Report Number
- 1823260-2026-01291
- Event Type
- Malfunction
- Date Received
- April 6, 2026
- Date of Event
- March 14, 2026
- Report Date
- April 24, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- MMI
- PMA / PMN Number
- K201441
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE E 801 ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
MEDWATCH FIELD B3 DATE OF EVENT HAS BEEN UPDATED.
Description of Event or Problem · 0
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TROPONIN T HS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. WHEN USING THE STAT APPLICATION OF THE ASSAY, THE SAMPLE RESULTED IN TROPONIN T VALUES OF 104 NG/L AND 11 NG/L. WHEN USING THE STANDARD APPLICATION OF THE ASSAY, THE SAMPLE RESULTED IN TROPONIN T VALUES OF < 13 NG/L AND < 13 NG/L.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 850452 | ELECSYS TROPONIN T HS | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | MMI | ROCHE DIAGNOSTICS | 847376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |