FDA Adverse Event
Malfunction
Summary report: N
ELECSYS TROPONIN T HS
MDR report key: 20224207
·
Received September 16, 2024
Report
- Report Number
- 1823260-2024-02670
- Event Type
- Malfunction
- Date Received
- September 16, 2024
- Date of Event
- August 21, 2024
- Report Date
- October 10, 2024
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- MMI
- PMA / PMN Number
- K201441
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 51.2 NG/L THE REPEAT RESULTS WERE 30.1 NG/L AND 11.0 NG/L. THE SAMPLE WAS RECENTRIFUGED AND ALIQUOTED THEN REPEATED WITH A RESULT OF 9.0 NG/L. THIS RESULT WAS BELIEVED TO BE CORRECT BASED ON THE CLINICAL PICTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1107364 | ELECSYS TROPONIN T HS | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | MMI | ROCHE DIAGNOSTICS | 77052801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female |