BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2771709 · Received October 4, 2012

    Report

    Report Number
    3008382007-2012-04760
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 9, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(6) ALLEGING AN ISSUE WITH THE PATTERN MESSAGING ON HER ONETOUCH VERIO IQ METER. THE CUSTOMER CARE ADVOCATE (CCA) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF SHE MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. THE PATIENT ALLEGED THE "HYPER PATTERN ALERT" WAS NOT WORKING; HOWEVER, THE PATIENT DID NOT SPECIFY DEVELOPING SYMPTOMS OR RECEIVING TREATMENT DUE TO THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THERE IS NO EVIDENCE THE PATIENT RECEIVED MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PATTERN MESSAGING ISSUE REMAINED UNRESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR