FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152564
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00227
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- May 9, 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 COULD NOT CALIBRATE THE AXSYM RUBELLA IGG REAGENT LOT# 58295M100 WITH THE MASTER CALIBRATOR LOT#600003M100. ERROR CODES 1001 (CALIBRATION CHECK FAILURE, A/B RATIO TOO HIGH) AND 1111 (MASTER CALIBRATOR 1 TOO HIGH) WERE GENERATED. THE ISSUE WAS RESOLVED AFTER CENTRIFUGING THE CALIBRATOR BEFORE CALIBRATION. 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 | 58295M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |