FDA Adverse Event
Other
Summary report: N
ABBOTT AXSYM SYSTEM
MDR report key: 272251
·
Received March 30, 2000
Report
- Report Number
- 1628664-2000-00017
- Event Type
- Other
- Date Received
- March 30, 2000
- Date of Event
- October 25, 1999
- Report Date
- March 29, 2000
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 10/25/1999, THE ACCOUNT REPORTED A NEGATIVE AXSYM HEPATITIS C VIRUS RESULT (S/CO= 0.23). PT WAS TESTED AT ANOTHER LAB WITH THE IMMUNOBLOT ASSAY AND WAS POSITIVE. THE SAMPLE WAS RETESTED ON THE AXSYM AND WAS POSITIVE (S/CO=43). ON A THIRD METHOD (UNKNOWN) THE PT WAS ALSO POSITIVE (S/CO=38). NO INJURY REPORTED.
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 | UNKNOWN | LIST NUMBER 3B44.| ABBOTT AXSYM HEPATITIS C VIRUS REAGENT, |