FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152669
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00264
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- April 18, 2008
- Report Date
- April 18, 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
- MY
- 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 HAS BEEN HAVING INTERMITTENT PROBLEMS WITH THE RUBELLA CALIBRATION ON THE AXSYM ANALYZER IN 2008. THE CUSTOMER STATED THAT, THE STABILITY WAS UNPREDICTABLE AND THAT THE NEGATIVE CONTROL WAS GIVEN OUT OF RANGE RESULTS. THE CUSTOMER RECEIVED A NEW LOT OF CALIBRATOR AND FOUND THAT IT RECOVERED GOOD RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS 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 | 56659M200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |