FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152684
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00295
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- February 7, 2008
- Report Date
- February 8, 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
- OTHER
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 CONTACTED ABBOTT REPORTING SEVERAL CALIBRATION FAILURES FOR THE AXSYM RUBELLA IGG ASSAY, WHERE ERROR CODE 1111 (CALLIBRATION CHECK FAILURE, M-CAL 1, RESPONSE TOO LARGE) WAS GENERATED. THE CUSTOMER'S MAINTENANCE PROCEDURES WERE REVIEWED AND THE CUSTOMER WAS ADVISED TO CENTRIFUGE THE RUBELLA CALIBRATORS. THE CUSTOMER STATED RECALIBRATION FAILE TWICE WITH NEW REAGENT AND NEW MASTER CALIBRATORS, THEREFORE, THE CUSTOMER REPLACED THE MATRIX CELLS AND CENTRIFUGED THE CALIBRATORS AND THE RECALIBRATION WAS SUCCESSFUL. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED BY THE CUSTOMER.
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 | 55922M101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LOT#57959M100| AXSYM RUBELLA MASTER CALIBRATORS| AXSYM ANALYZER| AXSYM RUBELLA MASTER CALIBRATORS| LOT# 51056M200 |