FDA Adverse Event
Malfunction
Summary report: N
COBAS 8000 E 801 MODULE
MDR report key: 10842590
·
Received November 16, 2020
Report
- Report Number
- 1823260-2020-02888
- Event Type
- Malfunction
- Date Received
- November 16, 2020
- Date of Event
- October 24, 2020
- Report Date
- December 1, 2020
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K060373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
THE INITIAL REPORTER RECEIVED A QUESTIONABLE TROPONIN T HS RESULT FOR ONE PATIENT FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 8.23 PG/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AS IT DID NOT MATCH THE CLINICAL PICTURE. THE REPEAT RESULTS WERE 132, 130, AND 139 PG/ML. THE REAGENT LOT NUMBER WAS 47003401 WITH AN EXPIRATION DATE OF 31-JUL-2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1313103 | COBAS 8000 E 801 MODULE | IMMUNOCHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS | E801 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |