FDA Adverse Event
Other
Summary report: N
AXSYM HCV 3.0
MDR report key: 589090
·
Received April 7, 2005
Report
- Report Number
- 1628664-2005-00013
- Event Type
- Other
- Date Received
- April 7, 2005
- Date of Event
- March 7, 2005
- Report Date
- April 7, 2005
- Manufacturer
- ABBOTT GMBH & CO. KG
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A NONREACTIVE AXSYM HCV V3.0 RESULT OF 0.30 S/CO WAS GENERATED ON A PRESURGICAL PATIENT THAT CLAIMED TO BE HCV POSITIVE. THE SAMPLE TESTED POSITIVE USING ACCESS HCV METHOD(1.90 X/CO). THE CUSTOMER RECALIBRATED THE AXSYM HCV REAGENT AND RECENTRIFUGED THE SAMPLE WHICH TESTED NONREACTIVE AGAIN AT 0.87 S/CO. A NONREACTIVE AXSYM HCV RESULT OF 0.68 S/CO WAS GENERATED ON A DIFFERENT PATIENT SAMPLE THAT TESTED POSITIVE AT 4.7 S/CO ON ACCESS HCV METHOD. ADDITIONAL TESTING IS PLANNED BY THE CUSTOMER TO DETERMINE HCV STATUS OF THE PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM HCV 3.0 | IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HEPAT | JJE | ABBOTT GMBH & CO. KG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | ABBOTT AXSYM ANALYZER, LIST 7A83-97, SERIAL 8424. |