FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 180808
·
Received August 3, 1998
Report
- Report Number
- 1628664-1998-00072
- Event Type
- Other
- Date Received
- August 3, 1998
- Date of Event
- July 4, 1998
- Report Date
- August 3, 1998
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Description of Event or Problem · 1
ON 7/4/1998, THE ACCOUNT REPORTED A NEGATIVE ETHANOL RESULT OR 0.0 MG/DL. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS RETESTED. A POSITIVE RESULT OF 352 MG/DL WAS OBTAINED. 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 | NO INFO | AXSYM ETHANOL REAGENT, LIST NUMBER 3B32-20 |