FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1063589
·
Received June 19, 2008
Report
- Report Number
- 1415939-2008-00161
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- May 16, 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 1018: CALIBRATION CHECK FAILURE, CAL A, RESULT TOO HIGH, ON THE AXSYM ANALYZER. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) PROVIDED INSTRUCTION AND ASKED THE CUSTOMER TO CHECK THE DISPENSE VOLUMES, DECONTAMINATE THE MUP, CLEAN THE OPTICS LINE AND CENTRIFUGE THE CALIBRATOR. 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 | 58294M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | AXSYM ANALYZER |