BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINALYSIS REAGENT STRIPS COMPLETE 10 PARAMETER TEST STRIPS

    MDR report key: 6794373 · Received August 12, 2017

    Report

    Report Number
    MW5071580
    Event Type
    Malfunction
    Date Received
    August 12, 2017
    Date of Event
    August 4, 2017
    Report Date
    August 12, 2017
    Manufacturer
    HEALTHYWISER LLC
    Product Code
    LJX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM CONCERNED ABOUT THE EFFICACY OF THE HEALTHYWISER URINALYSIS REAGENT STRIPS 10 PARAMETER TEST. DURING MY ANNUAL PHYSICAL WITH MY INTERNIST, A URINE TEST DETECTED TRACE BLOOD IN MY URINE. THE FOLLOWING WEEK I PURCHASED AN IN-HOME URINE TEST (HEALTHYWISER URINALYSIS REAGENT STRIPS) THAT CLAIMS TO BE ABLE TO DETECT BLOOD IN URINE. MY WIFE, AN RN, ADMINISTERED 4 TESTS, AND EACH TIME THE HEALTHYWISER STRIPS DID NOT DETECT BLOOD IN URINE. IN A SUBSEQUENT FOLLOW-UP WITH A UROLOGIST, HIS TEST SHOWED THAT I INDEED HAD TRACE BLOOD IN MY URINE AS FOUND IN THE ORIGINAL URINE TEST BY MY INTERNIST. I AM NOW UNDERGOING VARIOUS TESTS TO PINPOINT THE CAUSE OF THE BLOOD IN MY URINE. HERE'S MY POINT; I AM CONCERNED THAT THE HEALTHYWISER PRODUCT IS NOT SENSITIVE ENOUGH TO DETECT BLOOD IN URINE AS IT CLAIMS. THIS MIGHT CREATE A HARMFUL SITUATION IF A CONSUMER USES THE PRODUCT, FEELS ASSURED THAT HE/SHE DOES NOT HAVE BLOOD IN THE URINE, WHEN IN FACT HE/SHE DOES... WHICH MAYBE CAUSE FOR CONCERN. WHILE IT MAY BE TRUE THAT THE BATCH OF PRODUCT I USED MAY BE DEFECTIVE, I RECOMMEND THAT THE FDA CHECK THE EFFICACY OF THIS PRODUCT OVERALL TO BE SURE THAT IT CAN ACCURATELY DETECT THE 10 CONDITIONS THAT IT CLAIMS N DETECT. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570867 URINALYSIS REAGENT STRIPS COMPLETE 10 PARAMETER TEST STRIPS TEST URINE LEUKOCYTE LJX HEALTHYWISER LLC 05/22/2017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other