FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 285595
·
Received July 10, 2000
Report
- Report Number
- 1628664-2000-00045
- Event Type
- Other
- Date Received
- July 10, 2000
- Date of Event
- June 8, 2000
- Report Date
- June 30, 2000
- Manufacturer
- ABBOTT MFG, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON JUNE 8, 2000, THE CUSTOMER REPORTED OUT AN AXSYM BETA-HUMAN CHORIONIC GONADOTROPIN RESULT OF <2.0MIU/ML. PHYSICIAN QUESTIONED RESULT. THE SAMPLE WAS RETESTED, YIELDING A VALUE OF >1000 MIU/ML. WHEN THE SAMPLE WAS DILUTED 1:200, THE SAMPLE YIELDED A VALUE OF 1655.12MIU/ML. A CORRECTED REPORT WAS ISSUED. THERE WAS NO IMPACT ON PT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT AXSYM SYSTEM | AUTOMATED IMMUNOASSAY ANALYZER | JJE | ABBOTT MFG, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | LIST NUMBER 7A59-22.| AXSYM BETA-HUMAN CHORIONIC GONADOTROPIN ASSAY, |