FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 171605
·
Received June 5, 1998
Report
- Report Number
- 1628664-1998-00052
- Event Type
- Other
- Date Received
- June 5, 1998
- Date of Event
- May 7, 1998
- Report Date
- June 4, 1998
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON 05/07/1998 THE ACCOUNT REPORTED A FALSE NEGATIVE BETA-HUMAN CHORIONIC GONADOTROPHIN RESULT, WHICH WAS RUN ON THE AXSYM ANALYZER. THE RESULT DID NOT MATCH THE PT'S CLINICAL EVAL AND WAS QUESTIONED BY THE PHYSICIAN. ON 05/09/1998 THE SAMPLE WAS RETESTED GIVING 125,200/118,200 UI/L. NO REPORT OF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT AXSYM SYSTEM | AUTOMATED IMMUNOASSAY ANALYZER | JJE | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | LIST NUMBER 7A59-20.| AXSYM BETA-HUMAN CHORIONIC GONADOTROPHIN REAGENT, |