FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 275195
·
Received April 20, 2000
Report
- Report Number
- 1628664-2000-00021
- Event Type
- Other
- Date Received
- April 20, 2000
- Date of Event
- March 15, 2000
- Report Date
- April 14, 2000
- Manufacturer
- ABBOTT MFG, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON MARCH 15, A CUSTOMER REPORTED OUT AN AXSYM BETA-HUMAN CHORIONIC GONADOTROPHIN RESULT OF 28.39 MLU/ML. THE 1:200 DILUTION WAS LESS THAN 800MLU/ML. THE PHYSICIAN HAD REQUESTED THAT A QUANTITATIVE TEST BE RUN FOLLOWING A QUALITATIVE TEST WHICH HAD BEEN NEGATIVE. TWO DAYS LATER THE CUSTOMER RAN A SAMPLE FROM THE SAME PT WHICH YIELDED A VALUE OF 31,058.98 MLU/ML. RETEST OF THE ORIGINAL AND SECOND SAMPLES YIELDED VALUES OF 24,000 AND 30,000 MLU/ML, RESPECTIVELY. PT CARE WAS NOT IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT AXSYM SYSTEM | MEIA FOR MEASUREMENT OF TOTAL BHCG | JJE | ABBOTT MFG, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | NUMBER 7A59-22.| AXSYM BETA-HUMAN CHORIONIC GONADOTROPHIN, LIST |