FDA Adverse Event
Malfunction
Summary report: N
AU5431 CLINICAL CHEMISTRY ANALYZER
MDR report key: 2022814
·
Received March 17, 2011
Report
- Report Number
- 2050012-2011-00774
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 17, 2011
- Report Date
- February 17, 2011
- Manufacturer
- BECKMAN COULTER MISHIMA K.K.
- Product Code
- JLB
- PMA / PMN Number
- K011720
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERVICE WAS DISPATCHED FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT NO OTHER PROBLEMS WERE SEEN ON OTHER CK TESTS OR ANY OTHER TESTS ON THE INSTRUMENT. REACTION MONITOR OD DATA FOR THIS EVENT WAS NO LONGER AVAILABLE ON THE INSTRUMENT. THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED CREATININE KINASE RESULT OF 851 U/L GENERATED ON (B)(4) CHEMISTRY ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON ANOTHER AU INSTRUMENT IN THE LAB AND THE RESULTS WERE 69 U/L AND 65 U/L. THERE WAS NO EFFECT TO PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AU5431 CLINICAL CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JLB | BECKMAN COULTER MISHIMA K.K. | AU5431-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |