BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3882472 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85947
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    IT WAS REPORTED BY THE CUSTOMER'S MOTHER THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. MOTHER STATED HIS ELECTROLYTES WERE REALLY BAD AND DEHYDRATED, BUT DID NOT HAVE DIABETIC KETOACIDOSIS. CUSTOMER'S MOTHER STATED THE CUSTOMER HAD A STRETCH OF FOUR DAYS WITHOUT USING INSULIN PUMP AND CHECKING HIS BLOOD GLUCOSE, THIS CAUSED HIM TO GO HIGH. CUSTOMER WAS NOT WEARING PUMP DURING HOSPITALIZATION. PARAMEDICS WERE CONTACTED; BLOOD GLUCOSE READING AT THIS TIME WAS 300-400MG/DL. THE BLOOD GLUCOSE READING WAS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357235 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization