FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 241768
·
Received September 21, 1999
Report
- Report Number
- 1628664-1999-00049
- Event Type
- Other
- Date Received
- September 21, 1999
- Date of Event
- August 11, 1999
- Report Date
- September 16, 1999
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Description of Event or Problem · 1
ON 8-11-99, THE ACCOUNT ABTAINED AN AXSYM B-HCG RESULT OF >1000 MLU/ML. THE SAMPLE WAS REPEATED 1:10 (909 MIU/ML) AND 1:200 (1223 MLU/ML). THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED AND WAS 5352 MLU/ML. PT WAS BEING MONITORED FOR POSSIBLE ECTOPIC PREGNANCY. THERE WAS NO IMPACT TO PT MGMT AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT AXSYM SYSTEM | AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS | JJE | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | ABBOTT AXSYM B-HCG REAGENT LIST #7A59. |