FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152612
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00249
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- February 27, 2008
- Report Date
- February 28, 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
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
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 DETERMINED THE CALIBRATION FAILURE DUE TO ELEVATED CALIBRATOR A OR MASTER CALIBRATOR 1 AND 2 WITH AN ERROR CODE GENERATED WHEN ATTEMPTING TO CALIBRATE AXSYM RUBELLA IGG REAGENT. THE CUSTOMER PERFORMED PIPETTING CHECK, REPLACED THE PROBE AND CHECKED THE DISPENSED AMOUNT IN THE DISPENSER TRYING TO 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 IF IGG ANTIBODY TO THE RUBELLA VIRUS | LFX | ABBOTT LABORATORIES | NA | 55922M101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |