FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 277898
·
Received May 11, 2000
Report
- Report Number
- 1628664-2000-00029
- Event Type
- Other
- Date Received
- May 11, 2000
- Date of Event
- April 10, 2000
- Report Date
- May 10, 2000
- Manufacturer
- ABBOTT MFG, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Description of Event or Problem · 1
ON 4/10/2000 THE ACCOUNT REPORTED AN AXSYM BETA HUMAN CHORIONIC GONADOTROPIN RESULT OF 233 MLU/ML. THE PT'S PREVIOUS RESULT FROM 4/4/2000 WAS 1000 MLU/ML. THE PHYSICIAN QUESTIONED THE RESULT FROM 4/10/2000. THE SAMPLE WAS REPEATED ON 4/12/2000 AND WAS 18,000 MLU/ML. ANOTHER SAMPLE WHICH WAS OBTAINED ON 4/12/2000 WAS RUN AND WAS 27,000 MLU/ML. NO INJURY WAS REPORTED.
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 | 32 YR | ABBOTT AXSYM B-HCG REAGENT LIST #7A59. |