FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152526
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00220
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- May 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
- ID, US
- 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 FAILED TO CALIBRATE THE AXSYM RUBELLA IGG REAGENT TWICE WITH AND ERROR CODE OF 1018 (CALIBRATOR A RATES TOO HIGH). THE SAMPLE PROBE WAS REPLACED ONE WEEK BEFORE THE INCIDENT. OTHER METHODS OF TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. 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 | 60943M101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |