FDA Adverse Event
Malfunction
Summary report: N
COULTER LH 750 HEMATOLOGY ANALYZER
MDR report key: 2444080
·
Received February 9, 2012
Report
- Report Number
- 1061932-2012-00316
- Event Type
- Malfunction
- Date Received
- February 9, 2012
- Date of Event
- January 14, 2012
- Report Date
- January 14, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKZ
- PMA / PMN Number
- K011342
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LEAK UNDER THE COULTER LH 750 HEMATOLOGY ANALYZER. CUSTOMER REPORTED THAT PATIENT 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 HOLE AT THE TUBING THROUGH FEED THROUGH FITTINGS FF79, FF80 AND FF82 OF THE INSTRUMENT. THE FSE REPLACED THE TUBING THROUGH THE FITTINGS AND VERIFIED THE REPAIRS WERE PERFORMED PER ESTABLISHED PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER LH 750 HEMATOLOGY ANALYZER | COUNTER, DIFFERENTIAL CELL | GKZ | BECKMAN COULTER, INC. | LH 750 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |