FDA Adverse Event
Malfunction
Summary report: N
AXSYM DIGOXIN III
MDR report key: 1010268
·
Received May 11, 2007
Report
- Report Number
- 2623532-2007-00207
- Event Type
- Malfunction
- Date Received
- May 11, 2007
- Date of Event
- February 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
- PA, 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 STATES THAT THEY ARE GETTING ERROR CODE 1113 (INVALID TEST RESULT, READ VALUE) WHEN RUNNING PTS SAMPLES USING THE AXSYM DIGOXIN III ASSAY. 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 |