BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3082052 · Received April 29, 2013

    Report

    Report Number
    3008382007-2013-09364
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 VERIOIQ METER BECAUSE WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED PRIOR TO THE START OF THE ALLEGED ISSUE SHE FELT "SHAKING, COLD, CLAMMY AND ABOUT TO PASS OUT." THE PATIENT REPORTED 15 MINUTES LATER THE ALLEGED ISSUE OCCURRED AT APPROXIMATELY 2-3PM ON AN UNKNOWN DATE. THE PATIENT REPORTED USING NON ADJUSTING INSULIN 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 HER BLOOD GLUCOSE WAS MEASURED ON ANOTHER DEVICE AND READINGS OF "343 AND 328MG/DL" WERE OBTAINED. THE PATIENT REPORTED SHE TREATED HERSELF WITH 4-5 UNITS OF HUMALOG 70/30 INSULIN. AT THE TIME OF TROUBLESHOOTING, THE CCA REVIEWED THE AUTO SHUT OFF BEHAVIOR WITH THE PATIENT AND THE ISSUE REMAINED UNRESOLVED. THE CCA CONFIRMED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE METER. THE BATTERY DID NOT NEED TO BE RECHARGED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT REPORTED BEING SYMPTOMATIC PRIOR TO THE START OF THE ALLEGED ISSUE, THEREFORE, THE METER COULD NOT HAVE CAUSED THE INJURY, AND THERE WAS NO DELAY IN TREATMENT. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE, THE ALLEGED ISSUE WAS UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184959 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3337639

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR