FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® CLINICAL CHEMISTRY ANALYZER REAGENT
MDR report key: 2432426
·
Received January 30, 2012
Report
- Report Number
- 2050012-2012-00301
- Event Type
- Malfunction
- Date Received
- January 30, 2012
- Date of Event
- January 2, 2012
- Report Date
- January 3, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- CKA
- PMA / PMN Number
- K883181
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 ALLEGED FLUID LEAKED AT THE BASE OF ONE REAGENT CARTRIDGE INVOLVING SYNCHRON UREA. THE CUSTOMER STATED THE LEAK STARTED WHEN THE CAP WAS REMOVED FROM THE CARTRIDGE. THE CUSTOMER PROPERLY DISCARDED THE LEAKING CARTRIDGE. NO PATIENT RESULTS WERE REPORTED TO BE AFFECTED. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCUS MEMBRANES. THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® CLINICAL CHEMISTRY ANALYZER REAGENT | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | CKA | BECKMAN COULTER, INC. | NA | T108098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNICEL DXC 600 SYNCHRON SYSTEM |