BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6111373 · Received November 17, 2016

    Report

    Report Number
    2032227-2016-43000
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA TELEPHONE CALL THAT THE BLOOD GLUCOSE RAN LOW TO 48 MG/DL. THE CUSTOMER TREATED WITH FOOD. THE DRIVE SUPPORT CAP APPEARED NORMAL AND RECESSED. THE RESERVOIR SHOWED THE SAME AMOUNT OF INSULIN THAT WAS SHOWN ON THE STATUS SCREEN. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP AND DISCUSS THE POSSIBLE CAUSES OF LOW BLOOD GLUCOSE WITH A HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WAS NOT REPLACED ORE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760485 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other