FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 227965
·
Received June 14, 1999
Report
- Report Number
- 1628664-1999-00032
- Event Type
- Other
- Date Received
- June 14, 1999
- Date of Event
- May 10, 1999
- Report Date
- June 10, 1999
- Manufacturer
- ABBOTT LABORATORIES, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 05/10/99 THE ACCOUNT REPORTED AN AXSYM B-HCG RESULT OF <2.0 MIU/ML. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. ANOTHER SAMPLE FROM THE PT WAS RUN ON 5/12/99 AND WAS 263 MIU/ML. THE SAMPLE FROM 5/10/99 WAS REPEATED AND WAS 178 MIU/ML AND 177.6 MIU/ML. THERE WAS NO IMPACT TO PT MGMT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT AXSYM SYSTEM | AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS | JJE | ABBOTT LABORATORIES, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | ABBOTT AXSYM B-HCG REAGENT LIST #7A59. |