FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® PREALBUMIN (PAB) TEST KIT
MDR report key: 2024491
·
Received March 19, 2011
Report
- Report Number
- 2050012-2011-00794
- Event Type
- Malfunction
- Date Received
- March 19, 2011
- Date of Event
- February 12, 2011
- Report Date
- February 17, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JZJ
- PMA / PMN Number
- CLASS1EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.
Description of Event or Problem · 1
THE USER REPORTED THAT ONE OF THE SYNCHRON PREALBUMIN (PAB) TEST KIT WAS LEAKING DUE TO A CRACK. THE CUSTOMER DID NOT REPORT ANY USER INJURY OR MEDICAL INTERVENTION IN ASSOCIATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® PREALBUMIN (PAB) TEST KIT | PREALBUMIN REAGENT | JZJ | BECKMAN COULTER INC. | NA | M010391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |