FDA Adverse Event
Malfunction
Summary report: N
COBAS 6000 E601 MODULE
MDR report key: 2969374
·
Received February 20, 2013
Report
- Report Number
- 1823260-2013-01049
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Date of Event
- February 4, 2013
- Report Date
- February 27, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JLW
- PMA / PMN Number
- K060373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
THREE SAMPLES WERE RETURNED FOR INVESTIGATION. THE PRESENCE OF MACRO TSH WAS IDENTIFIED IN THE PATIENT'S SAMPLES. THIS INTERFERENCE IS DOCUMENTED IN THE PACKAGE INSERT.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE THYROTROPIN (TSH) RESULTS FOR ONE PATIENT ON THEIR E601 ANALYZER. THE PATIENT'S INITIAL TSH RESULT WAS 98.53 MUI/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON A CENTAUR ANALYZER. THE RESULT WAS 14.09 MUI/L. THE BIOLOGIST IS QUESTIONING THE HIGH TSH RESULT AS THE PATIENT HAD NO CLINICAL SIGNS OF HYPOTHYROIDISM. THE PATIENT WAS NOT ADVERSELY AFFECTED. 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 |
|---|---|---|---|---|---|---|---|
| 73712 | COBAS 6000 E601 MODULE | IMMUNOCHEMISTRY ANALYZER | JLW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 009 YR | SPASFON| SMECTA |