FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152603
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00240
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- January 9, 2008
- Report Date
- January 9, 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
- TU
- 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 THE RUBELLA CALIBRATION FAILED WITH ERROR CODE 1048: CALIBRATION CHECK FAILURE, CAL A/B RATIO TOO HIGH, ON THE AXSYM ANALYZER. SYSTEM MAINTENANCE WAS PERFORMED BY THE ABBOTT FIELD SERVICE ENGINEER AND THE ASSAY RECALIBRATED WITHOUT RESOLUTION. NO IMPACT TO PT MGMT 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 | 52563M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |