FDA Adverse Event
Malfunction
Summary report: N
AXSYM DIGOXIN III
MDR report key: 1010068
·
Received May 11, 2007
Report
- Report Number
- 2623532-2007-00175
- Event Type
- Malfunction
- Date Received
- May 11, 2007
- Date of Event
- November 22, 2006
- Report Date
- April 11, 2007
- Manufacturer
- ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
- Product Code
- KXT
- PMA / PMN Number
- K061249
- Removal / Correction Number
- 2623532-4/10/07-003-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 COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER STATES THAT WHILE PERFORMING A CORRELATION STUDY BETWEEN THE AXSYM DIGOXIN II ASSAY VS. THE AXSYM DIGOXIN III ASSAY, THEY NOTED THAT PTS SAMPLES RESULTS GENERATED ON THE AXSYM DIGOXIN III WERE HIGHER COMPARED TO AXSYM DIGOXIN II. FOR EXAMPLE, A PT SAMPLE GENERATED A RESULT OF 2.5 NG/ML USING THE AXSYM DIGOXIN II. THERE WAS NO IMPACT TO PTS MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM DIGOXIN III | MEIA FOR THE MEASUREMENT OF DIGOXIN | KXT | ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. | NA | 42722Q100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | AXSYM ANALYZER |