FDA Adverse Event
Malfunction
Summary report: N
COULTER® LH750 HEMATOLOGY ANALYZER
MDR report key: 2884669
·
Received December 24, 2012
Report
- Report Number
- 1061932-2012-02875
- Event Type
- Malfunction
- Date Received
- December 24, 2012
- Date of Event
- November 30, 2012
- Report Date
- November 30, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKZ
- PMA / PMN Number
- K011342
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE COULTER LH 750 HEMATOLOGY ANALYZER LEAKED BLOODY FLUID ONTO THE COUNTER. THE CUSTOMER WAS WEARING A LAB COAT AND GLOVES WHEN THE LEAK WAS DISCOVERED. THERE WAS NO REPORT OF INJURY OR EXPOSURE, AND MEDICAL ATTENTION WAS NOT SOUGHT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED, BUT THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THE FIELD SERVICE ENGINEER (FSE) FOUND A LEAK AT THE DIFF SHEAR VALVE. THE FSE REPLACED THE VALVE AND RESOLVED THE LEAK. THE SERVICE ACTIVITY PERFORMED WAS VERIFIED PER ESTABLISHED PROCEDURES, AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER® LH750 HEMATOLOGY ANALYZER | DIFFERENTIAL CELL COUNTER | GKZ | BECKMAN COULTER, INC. | LH750 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |