FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 279016
·
Received May 19, 2000
Report
- Report Number
- 1628664-2000-00033
- Event Type
- Other
- Date Received
- May 19, 2000
- Date of Event
- April 17, 2000
- Report Date
- May 18, 2000
- Manufacturer
- ABBOTT MFG, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Description of Event or Problem · 1
ON APRIL 17, 2000, CUSTOMER REPORTED AN AXSYM BETA-HUMAN CHORIONIC GONADOTROPIN VALUE OF 1949.00MIU/ML FOR A PT SAMPLE. ON 4/18 AS A RANDOM CHECK, THE SAMPLE WAS REPEATED WITH A RESULT OF 0.18MIU/ML. THE SAMPLE WAS ASSAYED A THIRD TIME AND YIELDED A VALUE OF 0.0MIU/ML. THE CUSTOMER NOTIFIED PHYSICIAN OF THE CORRECTED VALUE. THERE IS NO REPORT OF IMPACT ON PT MANAGEMENT.
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 | 27 YR | AXSYM BHCG ASSAY. |