FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CONTROL
MDR report key: 2589379
·
Received May 25, 2012
Report
- Report Number
- 2050010-2012-00018
- Event Type
- Malfunction
- Date Received
- May 25, 2012
- Date of Event
- April 30, 2012
- Report Date
- April 30, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJY
- PMA / PMN Number
- K003488
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
BECKMAN COULTER, INC (BEC) PERSONNEL IN THE CUSTOMER SERVICE DEPARTMENT FOUND TWO KITS OF SYNCHRON CONTROL MULTI-LEVEL ASSAYED REAGENT LEAKED DUE TO LOOSE CAPS WHEN THEY UNPACKED A SHIPMENT. THERE WAS NO REPORT OF ERRONEOUS RESULTS GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON CONTROL | MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) | JJY | BECKMAN COULTER, INC. | M102420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |