FDA Adverse Event
Other
Summary report: N
COULTER PREPPLUS
MDR report key: 447327
·
Received March 5, 2003
Report
- Report Number
- 1023939-2003-00004
- Event Type
- Other
- Date Received
- March 5, 2003
- Date of Event
- February 3, 2003
- Report Date
- March 4, 2003
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JQW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ACCORDING TO THE CUSTOMER, WHEN CERTAIN PANELS WERE RUN TOGETHER ON THE PREPPLUS, THE INSTRUMENT FAILS TO WASH THE PROBE BETWEEN SAMPLES. THE FAILURE CAUSED A CARRY-OVER OF REAGENTS INTO THE DAUGHTER TUBES AND CROSS CONTAMINATION OF THE ANTIBODY VIALS. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. NO CHANGE PT TREATMENT HAS BEEN ATTRIBUTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER PREPPLUS | PIPETTING AND DILUTING STATION FOR CLINICAL USE | JQW | BECKMAN COULTER, INC. | PREPPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |