BEUDAMED
    FDA Adverse Event Summary report: N

    AT HOME DRUG TEST PHARATECH

    MDR report key: 490478 · Received September 24, 2003

    Report

    Report Number
    MW4003602
    Date Received
    September 24, 2003
    Report Date
    July 31, 2003
    Manufacturer
    PHAMATECH
    Product Code
    MVO
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT OWNS A CONSTRUCTION BUSINESS AND ROUTINELY TESTS THEIR EMPLOYEES FOR USE OF THE DRUG MARIJAUNA. FOR THE LAST 8 WEEKS THEY HAVE BEEN USING THE REFERENCED OVER-THE-COUNTER IN VITRO DIAGNOSTIC TEST KITS ON THEIR EMPLOYEES AND THEY HAVE CONSISTENTLY TESTED POSITIVE (WEEKLY TESTS) THEY BECAME SUSPICIOUS BECAUSE THEY WERE CERTAIN THAT NOT ALL THEM SMOKED MARIJUANA. SO THEY TESTED THEMSELVES 4 OR 5 TIMES OVER THE LAST MONTH AND THEY TESTED POSITIVE EVERY TIME INCLUDING TWO DAYS AGO. THEY CLAIM THEY HAVE NOT USED MARIJUANA. SO THEY ARE CLAIMING THAT THE TEST IS VERY DEFECTIVE IN THAT IT IS GIVING MANY FALSE POSITIVES. LABELING CLAIMS THAT IS 99% EFFECTIVE AND "FDA CLEARED" THEY STATED THAT (OBVIOUSLY) FALSE POSITIVES CAUSES ALOT OF PROBLEMS FOR USERS IN THE FORM OF LOST JOBS, INCORRECT DRUG USE INFO ON RECORDS, ETC. THERE IS AN APPROVED 510K FOR THIS TEST KIT AND MANY OTHERS (510K NUMBER K994220).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AT HOME DRUG TEST PHARATECH SINGLE PANEL TEST FOR MARIJUANA THC MVO PHAMATECH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *