FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152668
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00263
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- May 13, 2008
- Report Date
- May 13, 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
- AS
- 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 STATED THAT, THE RUBELLA IGG REAGENT CALIBRATION FAILED WITH ERROR CODE 1018: CALIBRATION CHECK FAILURE, CAL A, RESULTS TOO HIGH, AND ERROR CODE 1001: ASSAY CALIBRATION FAILURE, RUBELLA G, ON THE AXSYM ANALYZER. THE ABBOTT FIELD SERVICE ENGINEER (FSE) INSPECTED THE PROBES AND TUBING AND CALIBRATED BOTH PROBES. THE FSE ATTEMPTED TO RECALIBRATE BUT IT FAILED AGAIN. THE FSE THEN CENTRIFUGED THE CALIBRATOR, REPLACED THE NEGATIVE CONTROL AND RECALIBRATED SUCCESSFULLY. NO IMPACT TO PATIENT 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 | 58295M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |