FDA Adverse Event
Malfunction
Summary report: N
COULTER LH 750 SLIDEMAKER
MDR report key: 2626896
·
Received June 23, 2012
Report
- Report Number
- 1061932-2012-01959
- Event Type
- Malfunction
- Date Received
- June 23, 2012
- Date of Event
- May 29, 2012
- Report Date
- May 29, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKJ
- PMA / PMN Number
- CLASS I EXEM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 SOME MOISTURE IN THE TRAY UNDERNEATH THE SHUTTLE OF THE COULTER LH 750 SLIDEMAKER. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED 5-10 ML OF ISOTON IN THE UNIT. THE FSE FOUND A HOLE IN THE BLACK STRIPE I-BEAM TUBING THROUGH PINCH VALVE VL18. THE FSE REPLACED THE DAMAGED TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER LH 750 SLIDEMAKER | SPINNER, SLIDE, AUTOMATED | GKJ | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |