BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP

    MDR report key: 4132566 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-09317
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS PROVIDED TO INCLUDE EVENT DETAILS THAT WERE MISSING FROM OUR ORIGINAL MEDWATCH FORM.

    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

    CUSTOMER'S FATHER REPORTED THAT HE DID NOT REMEMBER ANY DETAILS RELATED TO THE HIGH BLOOD GLUCOSE EVENT AND THAT THE HIGH BLOOD GLUCOSE JUST HAPPENS DUE TO HAVING DIABETES. HE STATED THAT THE CUSTOMER CAME HOME FROM SCHOOL ONE DAY WITH A BLOOD GLUCOSE READING OF 438 MG/DL AND THAT THE RESERVOIR WAS ALMOST EMPTY. THEY DID A SET CHANGE AND CORRECTED AND FATHER STATED THAT HE DID NOT FEEL THE ISSUE WAS RELATED TO THE INSULIN PUMP. CUSTOMER'S FATHER DECLINED TO TROUBLESHOOT THE ISSUE WITH THE HIGH BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER CALLED TO GET HOLSTER REPLACED FOR CUSTOMER. CUSTOMER'S BLOOD GLUCOSE WAS 430 MG/DL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611401 BELT CLIP OYC MEDTRONIC MINIMED MMT-612

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR