FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1061599
·
Received June 17, 2008
Report
- Report Number
- 1415939-2008-00105
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- May 12, 2008
- Report Date
- June 2, 2008
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- LFX
- PMA / PMN Number
- K954045
- Removal / Correction Number
- 1415939-6/06/08-004-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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 REPORTING THEY WERE UNABLE TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY AND OBSERVED ERROR CODE 1018 (CALIBRATION CHECK FAILURE, CALIBRATOR A, RESULT TOO HIGH). THE CUSTOMER REPORTED ALL OTHER AXSYM ASSAYS HAVE NO CALIBRATION ISSUES. THE CUSTOMER WAS SENT A NEW LOT OF REAGENT AND CALIBRATORS, AND ACHIEVED SUCCESSFUL CALIBRATION. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM RUBELLA IGG ANTIBODY | MEIA FOR THE MEASUREMENT OF IGG ANTIBODY TO RUBELLA VIRUS | LFX | ABBOTT LABORATORIES | NA | 58295M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | AXSYM ANALYZER: LIST#07A83-03| LOT#55912M100| LOT#62167M200.| AXSYM RUBELLA CALIBRATORS: LIST#03B23-01| AXSYM RUBELLA CALIBRATORS: LIST# 09C29-01 |