BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6031116 · Received October 14, 2016

    Report

    Report Number
    2032227-2016-32207
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY WERE HOSPITALIZED ON (B)(6) 2016 AT 1:30 PM WITH A BLOOD GLUCOSE LEVEL OF 519 MG/DL. THE CUSTOMER WAS TREATED FOR THEIR BLOOD GLUCOSE WITH A BOLUS AND MANUAL INJECTIONS. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING AND WAS INFORMED THAT THE SENSOR NEEDS TO BE REPLACED. THE CUSTOMER WAS EDUCATED ON THE PROPER SITE AND INSERTION TECHNIQUE OF THE SENSOR TO AVOID ANY ISSUES IN THE FUTURE. THE CUSTOMER WAS SENT A REPLACEMENT SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681467 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other