FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1061569
·
Received June 17, 2008
Report
- Report Number
- 1415939-2008-00089
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- April 28, 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
- NV, 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 THE INABILITY TO CALIBRATE THE AXSYM RUBELLA IGG ASSAY AND OBSERVED ERROR MESSAGE 1018 (CALIBRATION CHECK FAILURE, CALIBRATOR A RESULTS TOO HIGH). A REVIEW OF THE INSTRUMENT MESSAGE HISTORY DETERMINED A RECENT SAMPLE PROBE CRASH. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE REQUESTED THE CUSTOMER REPLACE THE PROBE AND RECALIBRATE THE RUBELLA ASSAY. THE CUSTOMER REPORTED THE RECALIBRATION WAS UNSUCCESSFUL AND SENT BACK THE RUBELLA CALIBRATORS FOR INVESTIGATION PURPOSES. ADDITIONALLY, THE CUSTOMER STATED THERE WAS NO IMPACT TO PT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM RUBELLA IGG ANTIBODY | MEIA FOR THE MEASUREMENT OF IGM ANTIBODIES TO RUBELLA VIRUS | LFX | ABBOTT LABORATORIES | NA | 58295M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | AXSYM RUBELLA CALIBRATORS: LOT# 55912M100| AXSYM ANALYZER |