FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA LGG ANTIBODY
MDR report key: 1341435
·
Received March 12, 2009
Report
- Report Number
- 1415939-2008-00289
- Event Type
- Malfunction
- Date Received
- March 12, 2009
- Date of Event
- January 31, 2008
- Report Date
- January 31, 2008
- 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 FAILED CALIBRATION OF THE AXSYM RUBELLA LGG ASSAY WHERE ERROR CODE 1048 (CALIBRATION CHECK FAILURE, CALA/B, RATIO TOO LARGE) WAS GENERATED. THE CUSTOMER DECONTAMINATED THE LINES, CLEANED AND CALIBRATED THE AXSYM OPTICS AND RECALIBRATED THE RUBELLA ASSAY, WHICH FAILED. THE CUSTOMER WAS ADVISED TO TROUBLESHOOT BY CENTRIFUGATION OF THE CALIBRATORS, AND WAS SENT A NEW LOT OF CALIBRATORS. UPON RECEIPT OF THE NEW CALIBRATORS, RECALIBRATION OF THE RUBELLA LGG ASSAY WAS ATTEMPTED AND FAILED. 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 | 56323M101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | RUBELLA MASTER CALIBRATORS| AXSYM ANALYZER| LOT# 53795M100 |