BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5909218 · Received August 26, 2016

    Report

    Report Number
    3004209178-2016-69612
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 20, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 PHONE CALL INDICATING THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS UNKNOWN THE EMERGENCY MEDICAL SERVICE WAS DISPATCHED AS RESULT OF LOW BLOOD GLUCOSE ON (B)(6) 2016. CUSTOMER WAS NOT ADMITTED TO THE HOSPITAL. CUSTOMER WAS TREATED BY EMERGENCY MEDICAL SERVICE WITH IV AND SUGAR JOT. CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE FOR PAST EVENT. THE CUSTOMER'S SPOUSE STATED THAT THE BLOOD GLUCOSE WAS 40 MG/DL. CUSTOMER WAS ADVISED TO MONITOR PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558080 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization