BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3072138 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08691
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 1, 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
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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) ALLEGING HIS ONETOUCH VERIO IQ METER WAS PROMPTING AN UNKNOWN ERROR MESSAGE WHEN HE WAS ATTEMPTING TO TEST HIS BLOOD GLUCOSE AND THE METER WAS POWERING OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS UNSURE OF WHEN THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED USING NOVOLOG INSULIN AND ANOTHER MEDICATION TO MANAGE HIS DIABETES. THE PATIENT DENIED MAKING ANY CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED AT AN UNKNOWN TIME HE DEVELOPED SYMPTOMS OF "SWEATING AND SHAKING." THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO ASSIST THE PATIENT TO RESOLVE THE ALLEGED ISSUE. THE CCA CONFIRMED THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT SINCE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, HE WAS UNABLE TO TEST, AND THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA. THIS PI CONTAINS INFORMATION FROM RELATED PIS #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174619 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3404974

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening