BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP PUMP CLEAR

    MDR report key: 4032451 · Received August 25, 2014

    Report

    Report Number
    2032227-2014-10526
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP CLIP BROKE WHILE SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS REPORTED AT 48 MG/DL AT THE TIME OF THE INCIDENT. A REPLACEMENT CLIP IS BEING SENT OUT AS A COURTESY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513247 BELT CLIP PUMP CLEAR INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-640CL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening