BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMBRIDGE BIOTECH HIV-1 WESTERN BLOT

    MDR report key: 260139 · Received January 24, 2000

    Report

    Report Number
    MW1018010
    Event Type
    Malfunction
    Date Received
    January 24, 2000
    Manufacturer
    CAMBRIDGE BIOTECH/CALYPTE BIOMEDICAL
    Product Code
    MVW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SAMPLES COLLECTED FOR ROUTINE HIV SCREENING THAT WERE REPEATEDLY REACTIVE USING AN FDA APPROVED EIA EXHIBITED ROBIN EGG SPECKLING WHEN TESTED USING THE FDA APPROVED WESTERN BLOT. SOME SAMPLES WERE RESOLVED USING A DIFFERENT LOT NUMBER; HOWEVER, OTHER SAMPLES WERE NOT RESOLVED. THE MFR WAS CONSULTED AND WAS ABLE TO REPRODUCE THE PROBLEM, BUT NO EXPLANATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMBRIDGE BIOTECH HIV-1 WESTERN BLOT WESTERN BLOT STRIPS MVW CAMBRIDGE BIOTECH/CALYPTE BIOMEDICAL * C9281

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other