ATHENA MULTILYTE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-10 for ATHENA MULTILYTE * manufactured by Wampole.

Event Text Entries

[20932549] This is to report a problem with a laboratory assay - non life threatening-the performance characteristics of the athena wampole/zues multilyte kit for ana screening does not at all correlate with patient history, signs and symptoms. The kit is designed to detect lupus or other connective tissue disease associated antibodies. As a "screening" method it has very poor correlation with pt presentation. This method has a sensitivity level well beyond what is considered normal, thereby detecting the presence of antibodies, especially rnp, and to a lessor extent, ss-b, scl-70 and jo-1. Rptr's laboratory has for the last 3 months routinely run these specimens by secondary method only to have very few "confirm" with what would be a high false positivity rate. For diagnosed lupus pts this test works well, however does not seem to be designed for screening "all comers. " rptr has unsuccessfully convinced the mfr that there is a problem. They refuse to confirm issues.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1037711
MDR Report Key663816
Date Received2006-01-10
Date of Report2006-01-10
Date Added to Maude2006-01-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameATHENA MULTILYTE
Generic NameANA TEST
Product CodeDHN
Date Received2006-01-10
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key653238
ManufacturerWAMPOLE
Manufacturer Address2 RESEARCH WAY PRINCETON NJ 08540 US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-01-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.