BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4990981 · Received August 11, 2015

    Report

    Report Number
    2032227-2015-26414
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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

    THE CUSTOMER REPORTED VIA (B)(6) HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE VALUE AT THE TIME OF INCIDENT WAS 600. SHE WENT TO THE BATHROOM AND REALIZED THAT THE CONNECTOR CAP WAS DETACHED FROM THE RESERVOIR, AND SHE IS UNSURE WHAT CAUSED THAT TO HAPPEN. TROUBLESHOOTING WAS INITIATED AND THE CUSTOMER CHANGED THE INFUSION SET. NO PRODUCTS WERE RETURNED AND THE CUSTOMER WAS SHIPPED ONE INFUSION SET AND ONE PUMP RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523639 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAB A4751NABJ

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other UNOMEDICAL INSULIN INFUSION SET