BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURO L7

    MDR report key: 11343883 · Received February 17, 2021

    Report

    Report Number
    MW5099467
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    February 14, 2021
    Report Date
    February 15, 2021
    Manufacturer
    SD BIOSENSOR, INC.
    Product Code
    JGY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRICKS LED TO BLEEDING; CURO L7 (O2 LIFECARE) IS THE PRODUCT. WE ORDERED THIS FDA APPROVED PRODUCT TO MEASURE THE LIPID PROFILE AT HOME. WE FOLLOWED THE PROCEDURE TO TAKE FINGER PRICK AND PUT THE BLOOD ON TEST STRIPS. EVEN AFTER PRICKING 7 FINGERS, ONE FINGER EACH TIME COLLECTING A LOT OF BLOOD FOR THE TEST THE DEVICE SHOWED US THE ERROR 'E1' WHICH ACCORDING TO THE PRODUCT BOOKLET MEANS THE TEST STRIPS ARE DEFECTIVE AND NEED TO BE CHANGED. HOWEVER THE EXPIRY DATE OF THE STRIPS 12/14/2021. THE PRICKS ON ALL THE FINGERS WERE SWOLLEN BECAUSE OF THE LANCET GIVEN WITH THE DEVICE. WE TRIED CALLING THE COMPANY BUT ALL THE CALLS WENT ON VOICEMAIL. THEY DO NOT HAVE A SAFETY OR PRODUCT COMPLAINT REPORTING NUMBER WHO CAN ATTEND TO THE OUR ADVERSE EVENT AND PRODUCT COMPLAINT AND THUS WE COULD NOT CONTACT THE COMPANY. IT ADVERTISES AS FDA APPROVED DEVICE BUT WE ARE NOT SURE IF IT A FDA APPROVED AS THEY DON'T EVEN HAVE A SAFETY REPORTING CONTACT NUMBER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236260 CURO L7 COLORIMETRIC METHOD, TRIGLYCERIDES JGY SD BIOSENSOR, INC. 99LA10G-2 LA0320003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other