FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 578096
·
Received February 21, 2005
Report
- Report Number
- 1628664-2005-00005
- Event Type
- Other
- Date Received
- February 21, 2005
- Date of Event
- January 13, 2005
- Report Date
- February 17, 2005
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JHE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE CUSTOMER OBSERVED AXSYM IMPRECISION WHILE TESTING PT SAMPLES. A SAMPLE TEST TESTED AXSYM TOXOPLASMA IGM NEGATIVE (0.36 INDEX VALUE) IN 2005 RETESTED TOXOPLASMA IGM POSTIVE AT ANOTHER FACILITY USING BECKMAN ACCESS METHOD. THE SAME PT WAS REDRAWN IN 02/2005 AND THE AXSYM TOXOPLASMA IGM RESULT WAS POSITIVE (2.75 INDEX VALUE). NO IMPACT TO PT MANAGEMDENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT AXSYM SYSTEM | AUTOMATED IMMUNAOSSAY ANALYZER | JHE | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | AXSYM TOXOPLASMA IGM REAGENT LIST 4B25-20 |