FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152503
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00216
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- March 4, 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
- CA
- Reporter Occupation
- OTHER
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 STATED THAT THERE WAS A CALIBRATION FAILURE OF AXSYM RUBELLA IGG REAGENT SINCE THE REAGENT LOT#57577M200 WAS USED WITH THE NEW CALIBRATOR. AN ERROR CODE OF 1111 (MASTER CALIBRATOR 1 TOO HIGH) AND ERROR CODE OF 1001 (CALIBRATION CHECK FAILURE, A/B RATIO TOO HIGH). THE CUSTOMER STATED THAT THERE IS NOTHING OUT OF THE ORDINARY IN THE MESSAGE HISTORY LOG AND THE MAINTENANCE IS UP TO DATE. 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 | 57577M201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |