FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® UREA REAGENT
MDR report key: 2470249
·
Received February 27, 2012
Report
- Report Number
- 2050012-2012-00606
- Event Type
- Malfunction
- Date Received
- February 27, 2012
- Date of Event
- January 31, 2012
- Report Date
- January 31, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- CDQ
- PMA / PMN Number
- K883181
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE IS NO INDICATION THE DEVICE WAS RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
THE AFFILIATE REPORTED THE CUSTOMER UNPACKED AN ESKY RECEIVED WITH REAGENT ORDER AND FOUND THE SYNCHRON UREA REAGENT BOX SOAKED AND RIPPED AND BOTH CARTRIDGES DAMAGED AND LEAKING. THE CUSTOMER REPORTED NO APPARENT DAMAGE TO THE ESKY. OTHER REAGENTS IN THE SAME ESKY WERE UNDAMAGED. CUSTOMER WAS WEARING LAB COAT, GLOVES AND SAFETY GLASSES AT TIME OF EVENT. NO REPORT OF DEATH OR SERIOUS INJURY WAS RECEIVED IN CONNECTION WITH EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® UREA REAGENT | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | CDQ | BECKMAN COULTER, INC. | NA | T108098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |