FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1063526
·
Received June 19, 2008
Report
- Report Number
- 1415939-2008-00107
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- February 18, 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 THEY RECEIVED THE ERROR CODE 1111: RUBELLA G CALIBRATION, MCAL 1 TOO HIGH, ON THE AXSYM ANALYZER. THE CUSTOMER DECONTAMINATED THE TUBING AND MUP, REPLACED THE MEIA LAMP, AND CHECKED THE MATRIX CELL EXPIRATION DATE. THE ABBOTT TECHNICAL ADVOCATE ADVISED THE CUSTOMER TO CENTRIFUGE THE CALIBRATORS WHICH RESOLVED THE ISSUE. NO IMPACT TO PATIENT MANAGEMENT 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 | 51885M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | AXSYM ANALYZER |