FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1063509
·
Received June 19, 2008
Report
- Report Number
- 1415939-2008-00123
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- March 10, 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
- 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 1111: M-CAL 1 CHECK TOO HIGH, RUBELLA G, ON THE AXSYM ANALYZER. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) ADVISED THE CUSTOMER TO RERUN THE CALIBRATION AFTER CENTRIFUGING THE CALIBRATORS. THE CTA ADVISED THE CUSTOMER NOT TO USE THE 2-POINT CALIBRATORS AND SENT THE CUSTOMER REPLACEMENT CALIBRATORS. 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 | 56659M201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | AXSYM ANALYZER| RUBELLA MCAL LIST# 3B23-30 |