FDA Adverse Event
Malfunction
Summary report: N
COULTER HMX ANALYZER WITH AUTOLOADER
MDR report key: 2589377
·
Received May 25, 2012
Report
- Report Number
- 1061932-2012-01683
- Event Type
- Malfunction
- Date Received
- May 25, 2012
- Date of Event
- April 30, 2012
- Report Date
- April 30, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKZ
- PMA / PMN Number
- K010765
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THERE WAS DILUENT LEAKING FROM BEHIND THE RED BLOOD CELL (RBC) APERTURE OF THE COULTER HMX ANALYZER WITH AUTOLOADER. CUSTOMER REPORTED THAT PATIENT'S RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND A SUBTLE LEAK AROUND THE RBC APERTURE. THE FSE REPLACED THE BATH O-RING AND TIGHTENED THE FITTINGS TO RESOLVE THE LEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER HMX ANALYZER WITH AUTOLOADER | COUNTER, DIFFERENTIAL CELL | GKZ | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |