FDA Adverse Event
Other
Summary report: N
AXSYM CMV-G REAGENT KIT
MDR report key: 588533
·
Received April 4, 2005
Report
- Report Number
- 1415939-2005-00005
- Event Type
- Other
- Date Received
- April 4, 2005
- Date of Event
- March 16, 2005
- Report Date
- April 1, 2005
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- LSO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATES THAT ONE PATIENT SAMPLE, IN THEIR 14TH WEEK OF PREGNANCY, GENERATED AN INITIAL AXSYM CMV IGG ASSAY RESULT OF 1.5 AU/ML (NEGATIVE). THE SAMPLE REPEATED WITH A RESULT OF GREATER THAN 250 AU/ML. THE PATIENT DILUTED THE SAMPLE AND GENERATED A FINAL RESULT OF 2328.8 AU/ML. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM CMV-G REAGENT KIT | IN VITRO TEST KIT FOR CMV ANTIBODIES | LSO | ABBOTT LABORATORIES | NA | 21188M200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | AXSYM ANALYZER LIST#: 7A83-01 |