BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY MULTISTRIP UROCHECK US - 10SG

    MDR report key: 662186 · Received November 28, 2005

    Report

    Report Number
    MW1037609
    Event Type
    Malfunction
    Date Received
    November 28, 2005
    Manufacturer
    RAC MEDICAL
    Product Code
    JMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    `PTR HAS BEEN USING ONE BOTTLE OF CLARITY MULTISTRIP UROCHECK 10SG LOT# 04825 EXPIRATION 10/2007 (THE BOTTLE CONTAINS THE DESSICANT AND IS KEPT PROPERLY). VIRTUALLY EVERY DIPSTICK HAS SHOWN A NITRITE POSITIVE. WHEN RPTR COMPARED THIS AGAINST A NEW BOTTLE (SAME LOT AND EXPIRATION DATE), IT IS OBVIOUS THAT ALL OF THESE NITRITE RESULTS ARE FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARITY MULTISTRIP UROCHECK US - 10SG * JMT RAC MEDICAL US-100SG 04825

    Patients

    Seq Age Sex Outcome Treatment
    1 *