FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152623
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00250
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- April 25, 2008
- Report Date
- April 25, 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
- 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 WAS UNABLE TO CALIBRATE THE AXSYM RUBELLA IGG REAGENT AFTER RECEIVING A NEW LOTS OF THE REAGENT AND THE CLIBRATOR. NEW REAGENT DID NOT WORK WITH AN OLD CALIBRATOR AND OLD REAGENT DID NOT WORK WITH NEW CALIBRATOR. 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 | 61151M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |