FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1063524
·
Received June 19, 2008
Report
- Report Number
- 1415939-2008-00106
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- February 15, 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 THAT AFTER REPLACING THE RUBELLA G REAGENT ON THE AXSYM ANALYZER, THE CALIBRATION FAILED. THE CUSTOMER HAD RECENTLY REPLACED THE PROBE AND THE ANALYZER WAS CHECK BY THE FIELD SVC REP. THE CUSTOMER DECONTAMINATED THE MUP WITHOUT RESOLUTION. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE ADVISED THE CUSTOMER TO CENTRIFUGE THE CALIBRATOR PRIOR TO PERFORMING THE CALIBRATION, WHICH RESOLVED THE ISSUE. NO IMPACT TO PT MGMT 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 | 57959M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | AXSYM ANALYZER |