FDA Adverse Event
Malfunction
Summary report: N
ELECSYS ANTI-TSHR
MDR report key: 19827536
·
Received July 25, 2024
Report
- Report Number
- 1823260-2024-02158
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- July 1, 2024
- Report Date
- September 3, 2024
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JZO
- UDI-DI
- 07613336160305
- PMA / PMN Number
- K193313
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE COBAS E411 RACK 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
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TSHR ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). INITIAL RESULT: 37.98 IU/L. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY AND THE SAME SAMPLE WAS THEN REPEATED ON THE SAME ANALYZER ON (B)(6) 2024. REPEAT RESULT: 1.75 IU/L. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358613 | ELECSYS ANTI-TSHR | THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | JZO | ROCHE DIAGNOSTICS | 76925802 | 07613336160305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |