FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1063608
·
Received June 19, 2008
Report
- Report Number
- 1415939-2008-00151
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- April 17, 2008
- Report Date
- June 2, 2008
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- LFX
- PMA / PMN Number
- K954045
- Removal / Correction Number
- 1415939-06/06/08-0004-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
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 STATED THE RUBELLA CALIBRATION FAILED WITH ERROR CODE 1048: CALIBRATION A/B RESULT TOO HIGH, ON THE AXSYM ANALYZER. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE INSTRUCTED THE CUSTOMER TO DO A COMPLETE AXSYM MAINTENANCE, CENTRIFUGE THE CAL A AND REPEAT THE CALIBRATION WHICH RESOLVED THE ISSUE. NO IMPACT TO PT 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 | NI | RUBELLA MCAL LIST# 3B23-30| AXSYM ANALYZER |