FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 2240187
·
Received September 9, 2011
Report
- Report Number
- 2050012-2011-05100
- Event Type
- Malfunction
- Date Received
- September 9, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 9, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JGS
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES WERE ALL SERUM. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND A CRACK IN THE ELECTROLYTE INJECTION CUP (EIC) VALVE AND REPLACED IT. FSE ALSO REPLACED A LINE IN THE ISE SYSTEM AND VERIFIED INSTRUMENT PERFORMANCE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT SODIUM (NA) RESULTS WERE DRIFTING LOW ON PATIENT SAMPLES RUN ON THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE LABORATORY REPORTED OUT 3 LOW NA RESULTS. WHEN THE ISSUE WAS NOTICED, SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT AND THE REPORTS WERE AMENDED. THE LABORATORY ONLY REPEATED NA AND DID NOT QUESTION POTASSIUM (K), CHLORIDE (CL), CALCIUM (CA) OR CO2 RESULTS. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JGS | BECKMAN COULTER INC. | DXC 600 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |