BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP

    MDR report key: 4133271 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-09354
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 THE PATIENT'S INSULIN PUMP HAS A BROKEN HOLSTER. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 411 MG/DL. TROUBLE SHOOTING WAS CONDUCTED. DEVICE IS NOT BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610829 BELT CLIP OYC MEDTRONIC MINIMED MMT-642

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR