BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4130320 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24410
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NOT 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 PT EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL. LEVEL GETS AS HIGH AS 600 MG/DL. TROUBLE SHOOTING WAS CONDUCTED AND WE EXPLAINED THE POSSIBLE REASONS FOR A HIGH BLOOD GLUCOSE LEVEL TO THE PT. THE DEVICE IS NOT BEING RETURNED. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578799 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR