FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® ANTISTREPTOLYSIN-O (ASO) REAGENT
MDR report key: 2184749
·
Received July 30, 2011
Report
- Report Number
- 2050012-2011-03918
- Event Type
- Malfunction
- Date Received
- July 30, 2011
- Date of Event
- June 30, 2011
- Report Date
- June 30, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GTQ
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A REPLACEMENT WILL BE SENT TO THE CUSTOMER. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEIR SYNCHRON ANTISTREPTOLYSIN-O (ASO) REAGENT CARTRIDGE WAS LEAKING FROM THE BOTTOM SEAM. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® ANTISTREPTOLYSIN-O (ASO) REAGENT | STREPTOCOCCUS SPP. EXOENZYME REAGENT | GTQ | BECKMAN COULTER, INC. | NA | M004439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |