FDA Adverse Event
Malfunction
Summary report: N
AXSYM FOLATE
MDR report key: 869125
·
Received June 22, 2007
Report
- Report Number
- 1415939-2007-00174
- Event Type
- Malfunction
- Date Received
- June 22, 2007
- Date of Event
- April 30, 2007
- Report Date
- June 18, 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
- SZ
- 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 COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE AXSYM FOLATE REAGENT CAP IS DEFECTIVE. AN ERROR CODE #5010 (MOTOR STEP LOSS, SOLUTION 4 PUMP, SAMPLING CENTER) AND ERROR CODE# 5013 (MOTOR STEP LOSS, PROBE UP/DOWN, SAMPLE CENTER) HAS OCCURRED DUE TO THIS ISSUE. THERE WAS NO IMPACT TO PATIENT 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 |