BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3082049 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09366
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 3, 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
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ON ALLEGING HER ONETOUCH VERIOIQ METER WAS HAVING A BATTERY CHARGE ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT DENIED USING ANY MEDICATIONS TO MANAGE HER DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED AT AN UNKNOWN TIME SHE "ALMOST PASSED OUT AND FELT JITTERY." THE PATIENT REPORTED ON (B)(6) 2013 AT 5AM, SHE HAD SOMETHING TO EAT OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE METER. THE PATIENT WAS ABLE TO PERFORM A RAPID CHARGE. THE PATIENT WAS FOUND TO BE USING THE CORRECT TEST STRIPS, HOWEVER DID NOT HAVE THEM AVAILABLE. WHEN THE PATIENT WAS INSTRUCTED TO PRESS AND HOLD THE POWER BUTTON FOR 10 SECONDS, THE ALLEGED ISSUE REMAINED UNRESOLVED. 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, THERE WAS A DELAY IN TREATMENT; THEREFORE, SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT TO PREVENT FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184958 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R