BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3192265 · Received June 27, 2013

    Report

    Report Number
    3008382007-2013-18617
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGED HIS ONETOUCH VERIOIQ METER WAS MISSING RESULTS. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST STARTED ON (B)(6) 2013 AT 5 PM. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED AT AN UNKNOWN TIME IN PROXIMITY TO THE ALLEGED ISSUE THE PATIENT DEVELOPED SYMPTOMS OF ¿SWEATING, DIZZY, CONFUSION.¿ THE PATIENT REPORTED ON (B)(6) 2013 AT 6 PM HE HAD SOMETHING TO EAT OR DRINK AS TREATMENT. DURING THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO DETERMINE THIS WAS THE FIRST TIME THE METER HAD BEEN USED AND THE CCA WAS UNABLE TO RESOLVE THE ALLEGED ISSUE WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292972 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3302178

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R