FDA Adverse Event
Other
Summary report: N
AXSYM TOXO IGM
MDR report key: 564053
·
Received May 21, 2004
Report
- Report Number
- 1415939-2004-00023
- Event Type
- Other
- Date Received
- May 21, 2004
- Date of Event
- April 27, 2004
- Report Date
- May 20, 2004
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- LGD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATES THAT A PT IN HER SIXTH MONTH OF PREGNANCY GENERATED AXSYM TOXOPLASMOSIS IGM ASSAY INDEX VALUES OF 0.456 AND 0.427 (NEGATIVE). THIS SAME PATIENT HAD PREVIOUSLY TESTED NEGATIVE (DATE UNKNOWN) WITH AN INDEX VALUE OF 0.486. THE PATIENT IS KNOWN TO BE POSITIVE FOR TOXOPLASMOSIS IGM. THE PRESENT SAMPLE TESTED POSITIVE FOR TOXOPLASMOSIS IGM ON TWO DIFFERENT COMPETITOR'S PLATFORMS. CONTROLS ON THE AXSYM ANALYZER HAVE BEEN WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM TOXO IGM | MEIA FOR DETECTION OF IGM AB TO TOXOPLASMA | LGD | ABBOTT LABORATORIES | NA | 08116M100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | AXSYM ANALYZER LIST#: 7A83-01. |