BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEST, URINE LEUKOCYTE

    MDR report key: 19645941 · Received June 28, 2024

    Report

    Report Number
    MW5156829
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    April 10, 2024
    Report Date
    June 27, 2024
    Manufacturer
    LIFE2O
    Product Code
    JIL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TEST RESULT FROM LIFE2O 14-PANEL URINE TEST: HIGH GLUCOSE LEVEL. VERIFIED TEST RESULT: NORMAL GLUCOSE LEVEL (LABORATORY TEST). DESCRIPTION: THE LIFE2O TEST REPORTED CRITICALLY HIGH GLUCOSE LEVELS, CAUSING ME TO SEEK EMERGENCY MEDICAL INTERVENTION. SUBSEQUENT LABORATORY TESTING THE SAME DAY CONFIRMED NORMAL GLUCOSE LEVELS, REVEALING THE LIFE2O TEST'S SEVERE INACCURACY AND THE UNDUE STRESS AND POTENTIAL HARM CAUSED BY THIS FALSE POSITIVE RESULT. DEVICE / ELECTRONIC PRODUCT NAME: 14-PANEL URINE TEST STRIPS FOR URINALYSIS 100CT, TESTING KIT FOR UTI, KETO, KETOSIS, PROTEIN, SPECIFIC GRAVITY, PH, KETONE, BILIRUBIN, VITAMIN C, CRE, SGR AND MORE. REFERENCE REPORT: MW5156830, MW5156831, MW5156832.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 10/25/2024 FOR REPORT MW5156829 TO UPDATE PROCODE. THE SEVERE INACCURACIES IN THE URINE TEST RESULTS HAVE EXPOSED ME TO SIGNIFICANT HEALTH RISKS, INCLUDING: - UNNECESSARY PANIC AND EMERGENCY MEDICAL VISITS, CAUSING UNDUE EMOTIONAL AND FINANCIAL STRESS. - POTENTIALLY HARMFUL HEALTH INTERVENTIONS BASED ON ERRONEOUS TEST RESULTS, RISKING SERIOUS MEDICAL COMPLICATIONS. DEVICE / ELECTRONIC PRODUCT NAME: 14-PANEL URINE TEST STRIPS FOR URINALYSIS 100CT, TESTING KIT FOR UTI, KETO, KETOSIS, PROTEIN, SPECIFIC GRAVITY, PH, KETONE, BILIRUBIN, VITAMIN C, CRE, SGR AND MORE. CONTACTED LIFE2O CUSTOMER SUPPORT ON (B)(6) 2024, EXPRESSING THE CRITICAL NATURE OF THESE INACCURACIES. THE RESPONSE WAS INADEQUATE AND FAILED TO ADDRESS THE UNDERLYING ISSUES. FOLLOWED ALL TROUBLESHOOTING STEPS AS OUTLINED IN THE USER MANUAL, WITHOUT RESOLUTION. VERIFIED THE DEVICE'S REPEATED INACCURACIES THROUGH MULTIPLE INDEPENDENT AND MEDICALLY VERIFIED LABORATORY TESTS. DEVICE / ELECTRONIC PRODUCT NAME: 14-PANEL URINE TEST STRIPS FOR URINALYSIS 100CT, TESTING KIT FOR UTI, KETO, KETOSIS, PROTEIN, SPECIFIC GRAVITY, PH, KETONE, BILIRUBIN, VITAMIN C, CRE, SGR AND MORE. REF REPORT: MW5156830.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683727 TEST, URINE LEUKOCYTE METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) JIL LIFE2O

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown