FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT
MDR report key: 2435461
·
Received February 1, 2012
Report
- Report Number
- 2050012-2012-00356
- Event Type
- Malfunction
- Date Received
- February 1, 2012
- Date of Event
- January 11, 2012
- Report Date
- January 11, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JFY
- PMA / PMN Number
- K091742
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2012, THE BECKMAN COULTER SITE IN (B)(4) REPORTED RECEIVING A CRACKED CONTAINER OF CREATININE REAGENT THAT HAD LEAKED UPON ARRIVAL. NO INJURY OR EXPOSURE WAS REPORTED BY THE WAREHOUSE OPERATOR. IT WAS DECIDED THAT AN MDR SHOULD BE FILED BECAUSE THE REAGENT CONTAINS MATERIAL OF ANIMAL ORIGIN, WHICH IS CONSIDERED POTENTIALLY INFECTIOUS, AND UPON RECUR, EXPOSURE MAY CAUSE SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT | ENZYMATIC METHOD, CREATININE | JFY | BECKMAN COULTER, INC. | M110026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |