FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON BILIRUBIN CALIBRATOR
MDR report key: 2382907
·
Received December 20, 2011
Report
- Report Number
- 2050012-2011-08497
- Event Type
- Malfunction
- Date Received
- December 20, 2011
- Date of Event
- October 27, 2011
- Report Date
- October 27, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- CIG
- PMA / PMN Number
- K934068
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS QUARANTINED BY A BECKMAN COULTER, INC. EMPLOYEE, AND CREDIT WAS ISSUED TO THE CUSTOMER WHO WAS TO RECEIVE THE SHIPMENT. NO ONE WAS HARMED BY OR EXPOSED TO THE LEAK. (B)(4).
Description of Event or Problem · 1
A BECKMAN COULTER, INC. EMPLOYEE REPORTED THAT WHILE UNPACKING A SHIPMENT PACKAGE, THE SYNCHRON BILIRUBIN CALIBRATOR, LOT #M103319, CONTAINED IN THAT SHIPMENT WAS LEAKING DUE TO BREAKAGE. NO ONE WAS HARMED BY OR EXPOSED TO THE FLUID THAT HAD LEAKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON BILIRUBIN CALIBRATOR | DIAZO COLORIMETRY, BILIRUBIN | CIG | BECKMAN COULTER, INC. | TOTAL/DIRECT BILIRUBIN CALIBRATOR | M103319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |