COBAS E 801 ANALYTICAL UNIT
Report
- Report Number
- 1823260-2024-03750
- Event Type
- Malfunction
- Date Received
- December 19, 2024
- Date of Event
- December 1, 2024
- Report Date
- January 15, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K060373
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EXPIRATION DATE FOR THE REAGENT WAS PROVIDED AS "JUN-2025". FURTHER INVESTIGATION WAS NOT POSSIBLE AS SAMPLE MATERIAL FROM THE PATIENT WAS NOT AVAILABLE. BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.
ADDITIONAL INFORMATION WAS RECEIVED ALLEGING THE PATIENT WAS A 10-YEAR-OLD CHILD. CLARIFICATION WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED. THE INVESTIGATION IS ONGOING.
THE REAGENT LOT NUMBER WAS 781598. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
THERE WAS AN ALLEGATION OF QUESTIONABLE FT3 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT THAT DID NOT FIT THE PATIENT'S CLINICAL PICTURE. THE INITIAL RESULT WAS 10.2 PMOL/L AND THE REPEAT RESULT WAS 9.27 PMOL/L. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON AN ARCHITECT ANALYZER, AND THE RESULT WAS = <1.3 PMOL/L. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER AND THE RESULT WAS 3.4 PMOL/L.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2097202 | COBAS E 801 ANALYTICAL UNIT | IMMUNOCHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS | E801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Female |