FDA Adverse Event
Malfunction
Summary report: N
COBAS E411 RACK SYSTEM
MDR report key: 2954032
·
Received February 11, 2013
Report
- Report Number
- 1823260-2013-00795
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 18, 2013
- Report Date
- February 11, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JLW
- PMA / PMN Number
- K961481
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURED IN (B)(6).
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE THYROTROPIN (TSH) RESULTS FOR ONE PATIENT ON THEIR E411 ANALYZER. THE PATIENT WAS BORN IN 1962. THE PATIENT'S INITIAL TSH RESULT WAS 3.17 MIU/ML. THE RESULT WAS GIVEN TO THE ATTENDING PHYSICIAN WHO DECIDED TO INITIATE REPEAT TESTING. THE SAMPLE WAS REPEATED ON ANOTHER E411, SERIAL NUMBER NOT PROVIDED, WITH RESULTS SIMILAR TO THE INITIAL RESULTS. THE SAMPLE WAS TESTED ON A SIEMENS CENTAUR ANALYZER WITH A RESULT OF 1.76 MIU/ML. THERE WERE NO ADVERSE EVENTS. THE TSH REAGENT LOT NUMBER WAS 170904 AND THE EXPIRATION DATE WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58036 | COBAS E411 RACK SYSTEM | IMMUNOCHEMISTRY ANALYZER | JLW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TETRACEPAN| ESMETRAZOL| IBUPROPHEN| NOVALGIN (TROPFEN) DROPS |