BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN PUMP BELT CLIP

    MDR report key: 4141776 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33550
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A CUSTOMER WAS ADMITTED TO THE HOSPITAL BECAUSE THE INFUSION SET NEEDLE BROKE INSIDE THE PATIENT'S SKIN. THE CALLER WAS THE PATIENT'S MOTHER. THE PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE HOSPITAL VISIT WAS 240 MG/DL. THE PATIENT WAS ALSO ADMITTED TO THE HOSPITAL TO SURGICALLY REMOVE A HERNIA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621198 INSULIN PUMP BELT CLIP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-640

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization