BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEARVIEW FLU A/B

    MDR report key: 748942 · Received September 13, 2005

    Report

    Report Number
    MW1036614
    Event Type
    Other
    Date Received
    September 13, 2005
    Report Date
    September 13, 2005
    Manufacturer
    WAMPLE LABORATORIES
    Product Code
    GRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWENTY EIGHT PERCENT NEGATIVE RESULTS FOR RAPID INFLUENZAE A/B TEST KIT BETWEEN 10/04 AND 2/15/2005. COMPANY NOTIFIED BY OUR LAB AND REPLIED THAT THIS WAS DUE TO "BAD LOT." REPLACEMENT KIT RESULTS WERE 33% FALSE NEGATIVES BETWEEN 2/16/2005 AND 04/2005. PHYSICIANS USE TEST TO MAKE DIAGNOSIS AND TREATMENT DECISIONS. PRODUCT LITERATURE CLAIMS 92% SENSITIVITY/100% SPECIFICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARVIEW FLU A/B RAPID INFLUENZAE TEST KIT GRP WAMPLE LABORATORIES * 79261
    2 CLEARVIEW FLU A/B RAPID INFLUENZAE TEST KIT GRP WAMPLE LABORATORIES * 80125
    3 CLEARVIEW FLU A/B RAPID INFLUENZAE TEST KIT GRP WAMPLE LABORATORIES * 82435

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other