FDA Adverse Event
Malfunction
Summary report: N
ELECSYS TROPONIN T HS
MDR report key: 17695135
·
Received September 6, 2023
Report
- Report Number
- 1823260-2023-02906
- Event Type
- Malfunction
- Date Received
- September 6, 2023
- Date of Event
- August 9, 2023
- Report Date
- October 26, 2023
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- MMI
- PMA / PMN Number
- K201441NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 0
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. THE INITIAL TROPONIN RESULT WAS 303 NG/L. THE SAMPLE WAS REPEATED 3 TIMES AND THE RESULTS WERE 4.38 NG/L WITH FLAG, 4.42 NG/L, AND 4.11 NG/L WITH FLAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1560569 | ELECSYS TROPONIN T HS | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | MMI | ROCHE DIAGNOSTICS | 64240501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male |