FDA Adverse Event
Malfunction
Summary report: N
AXSYM FOLATE
MDR report key: 857457
·
Received May 30, 2007
Report
- Report Number
- 1415939-2007-00085
- Event Type
- Malfunction
- Date Received
- May 30, 2007
- Date of Event
- March 23, 2007
- Report Date
- May 14, 2007
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- CGN
- PMA / PMN Number
- K972232
- Removal / Correction Number
- 1415939-5/1/07-004-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- 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 COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT WHILE CALIBRATING THE AXSYM FOLATE ASSAY, THE LID ON THE REAGENT PACK BROKE OFF DURING THE RUN AND CAUSED THE PROBE TO CRASH. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM FOLATE | AN ION CAPTURE ASSAY FOR THE QUANTITATIVE DETERMINATION OF FOLATE IN SERUM, PLAS | CGN | ABBOTT LABORATORIES | NA | 49488M200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | AXSYM ANALYZER LIST #7A83-01 |