BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUP

    MDR report key: 4160363 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25865
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REPORTED ISSUES WITH THE SENSORS. CUSTOMER ALSO STATES THAT THE BLOOD GLUCOSE READINGS ARE OFF. THE BLOOD GLUCOSE READING WAS 48 MG/DL AT ONE POINT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582199 530G INSULIN PUP OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR