FDA Adverse Event
Malfunction
Summary report: N
AXSYM DIGOXIN III
MDR report key: 1010027
·
Received May 11, 2007
Report
- Report Number
- 2623532-2007-00066
- Event Type
- Malfunction
- Date Received
- May 11, 2007
- Date of Event
- April 3, 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
- UT, 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 STATED THAT AN ERROR CODE# 1118 (INVALID TEST RESULT, INTERCEPT TOO LOW) WAS GENERATED ON PT SAMPLES ON THE AXSYM DIGOXIN ASSAY. THERE WAS NO IMPACT TO PT 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 | 46181Q100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | AXSYM ANALYZER LIST# 7A83-01 |