FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152528
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00222
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- March 26, 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
- CA
- 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 IS UNABLE TO CALIBRATE THE AXSYM RUBELLA IGG REAGENT, LOT# 60943M100 WITH THE MASTER CALIBRATOR, LOT# 60003M100. ERROR CODE 1018 (CALIBRATOR A RATES TOO HIGH) WAS GENERATED. ALL OTHER ASSAYS ARE PERFORMING WELL AND THE INSTRUMENT MAINTENANCE IS UP TO DATE. THE CUSTOMER WAS ABLE TO CALIBRATE WITH THE AXSYM RUBELLA IGG REAGENT LOT# 57577M201 AND THE SAME MASTER CALIBRATOR. 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 | 60943M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |