FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152524
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00218
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- May 17, 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
- SD, 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 FAILED TO CALIBRATE THE NEW AXSYM RUBELLA IGG REAGENT WITH AN EROR CODE OF 1048 (A/B RATIO TOO HIGH). THE CUSTOMER IS UNABLE TO RETRIEVE DATA FROM THE AXSYM. PARTICULATE MATTER WERE FOUND IN THE CALIBRATOR. THERE IS NO SIMILAR ISSUE WITH OTHER ASSAYS. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM RUBELLA IGG ANTIBODY | MEIA FOR THE MEASUREMENT OF IGG ANTIBODY TO THE RUBELLA VIRUS | LFX | ABBOTT LABORATORIES | NA | 60943M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |