FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA LGG ANTIBODY
MDR report key: 1341462
·
Received March 12, 2009
Report
- Report Number
- 1415939-2008-00276
- Event Type
- Malfunction
- Date Received
- March 12, 2009
- Date of Event
- November 29, 2007
- Report Date
- November 30, 2007
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- GOL
- PMA / PMN Number
- K954045
- Removal / Correction Number
- 1415939-6/06/08-004-C
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED ABBOTT REGARDING TWO FAILED AXSYM RUBELLA LGG CALIBRATIONS WHERE ERROR CODE 1111 (CALIBRATION CHECK FAILURE, MASTER CAL 1, RESPONSE TOO LARGE) WAS GENERATED. THE CUSTOMER WAS SENT A NEW LOT OF CALIBRATORS AND A SUCCESSFUL RUBELLA LGG CALIBRATION WAS ACHIEVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM RUBELLA LGG ANTIBODY | MEIA FOR THE MEASUREMENT OF LGG ANTIBODY TO THE RUBELLA VIRUS | GOL | ABBOTT LABORATORIES | NA | 52254M200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LOT# 50027M100| AXSYM RUBELLA MASTER CALIBRATORS| AXSYM ANALYZER |