FDA Adverse Event
Malfunction
Summary report: N
AXSYM RUBELLA IGG ANTIBODY
MDR report key: 1152643
·
Received September 10, 2008
Report
- Report Number
- 1415939-2008-00257
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- May 9, 2008
- Report Date
- May 9, 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 Occupation
- OTHER
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, THE RUBELLA CALIBRATION HAD FAILED ON THE AXSYM ANALYZER WITH CAL 1 OUT OF RANGE LOW. THE CUSTOMER STATED THE ISSUE WAS WITH TWO LOTS OF CALIBRATORS. THE CUSTOMER REPLACED THE CAL A WITH BUFFER AND RECALIBRATED SUCCESSFULLY. NO IMPACT TO PATIENT MANAGEMENT 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 | 58295M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER |