FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1063603
·
Received June 19, 2008
Report
- Report Number
- 1415939-2008-00156
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- May 13, 2008
- Report Date
- June 2, 2008
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- LFX
- PMA / PMN Number
- K954045
- Removal / Correction Number
- 1415939-06/06/08-004-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 THAT THE RUBELLA CALIBRATION FAILED ON THE AXSYM ANALYZER. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) INSTRUCTED THE CUSTOMER TO REPLACE THE MATRIX CELL LOT, REPLACE THE PROCESS AND SAMPLE PROBES, CALIBRATE THE MEIA, AND DECONTAMINATE THE TUBINGS AND MUP. THE CTA SENT THE CUSTOMER RUBELLA G 6-POINT CALIBRATORS. A FOLLOW-UP WITH THE CUSTOMER INDICATED THAT THE CUSTOMER HAD MADE SEVERAL ATTEMPTS TO CALIBRATE WITHOUT SUCCESS; HOWEVER, AFTER CENTRIFUGING THE CALIBRATORS, THE CALIBRATION PASSED. 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 | NI | AXSYM ANALYZER |