FDA Adverse Event
Malfunction
Summary report: N
LH 500 HEMATOLOGY ANALYZER
MDR report key: 2990785
·
Received March 5, 2013
Report
- Report Number
- 1061932-2013-00361
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 5, 2013
- Manufacturer
- BECKMAN COULTER
- Product Code
- GKZ
- PMA / PMN Number
- K032000
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MISALIGNED BACKWASH CUP. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED A LEAK OUT OF THE MANUAL ASPIRATION MODE OF THE LH 500 HEMATOLOGY ANALYZER WHEN THE ANALYZER WAS SWITCHED TO MANUAL MODE ONLY. THE CUSTOMER INDICATED THAT UNKNOWN AMOUNT OF LIQUID HAD LEAKED ONTO THE COUNTER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES AND EYEWEAR AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTED THE LEAK WAS DUE TO A MISALIGNED BACKWASH CUP. THE FSE ADJUSTED THE BACKWASH CUP AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93650 | LH 500 HEMATOLOGY ANALYZER | COUNTER, DIFFERENTIAL CELL | GKZ | BECKMAN COULTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |