FDA Adverse Event
Malfunction
Summary report: N
AXSYM DIGOXIN III
MDR report key: 1010260
·
Received May 11, 2007
Report
- Report Number
- 2623532-2007-00199
- Event Type
- Malfunction
- Date Received
- May 11, 2007
- Date of Event
- January 25, 2007
- 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
- ND, 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 THEY ARE GETTING ERROR CODE 1118 (INVALID TEST RESULT, INTERCEPT TOO LOW) AND ERROR CODE 1063 (INVALID TEST RESULT, CORRELATION COEFFICIENT TOO LOW) WHEN RUNNING PATIENTS SAMPLES ON THE AXSYM DIGOXIN III ASSAY. THERE WAS NO IMPACT TO PATIENTS 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 | LIST# 7A83-95| AXSYM ANALYZER |