BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELT CLIP

    MDR report key: 3981937 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-05710
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED AN ERROR AND WAS UNRESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE WAS 160 MG/DL. THE ALARM HISTORY OF THE INSULIN PUMP COULD NOT BE ACCESSED BECAUSE THE ALARM COULD NOT BE CLEARED. THE CUSTOMER STATED THAT THE DEVICE WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. THE CUSTOMER STATED THAT EVERY TIME THEY TRIED CLEARING THE ALARM THE SCREEN CLEARED, COUNTED DOWN, AND GAVE THE SAME ERROR ALARM. THE CUSTOMER COULD NOT REMOVE THE BELT CLIP FROM THE INSULIN PUMP BECAUSE IT WAS NOT UNLOCKING; THE CUSTOMER BROKE THE BELT CLIP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458450 BELT CLIP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-631CL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR