FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152568
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00232
- Event Type
- Malfunction
- Date Received
- September 10, 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
- IL, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITITAL 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 IS UNABLE TO CALIBRATE THE AXSYM RUBELLA IGG REAGENT. ERROR CODE 1111 (MASTER CALIBRATOR 1 TOO HIGH) WAS GENERATED DURING CALIBRATION. THE CUSTOMER WAS ADVISED TO CENTRIFUGE THE AXSYM RUBELLA IGG CALIBRATOR PRIOR TO RUNNING THE INSTRUMENT WHICH RESOLVED THE ISSUE. THERE WAS NO IMPACT TO PT MGMT 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 |