FDA Adverse Event
Malfunction
Summary report: N
COBAS 8000 COBAS ISE MODULE
MDR report key: 11544429
·
Received March 22, 2021
Report
- Report Number
- 1823260-2021-00891
- Event Type
- Malfunction
- Date Received
- March 22, 2021
- Date of Event
- February 11, 2021
- Report Date
- March 26, 2021
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K100853
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 FIELD SERVICE ENGINEER REPLACED THE ELECTRODE AND THE PROBES. CALIBRATION, QC, AND ISE CHECKS WERE ACCEPTABLE. THIS EVENT OCCURRED IN GBR. (UDI) # (B)(4).
Description of Event or Problem · 1
THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT GEN.2 SODIUM RESULTS FOR MULTIPLE PATIENT SAMPLES FROM THE COBAS 8000 COBAS ISE MODULE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438330 | COBAS 8000 COBAS ISE MODULE | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS | COBAS 8000 ISE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |