BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241739 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50662
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 31, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT THE CUSTOMER REQUIRED MEDICAL INTERVENTION BY EMERGENCY MEDICAL SERVICES DUE TO LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS UNKNOWN. THE CUSTOMER REPORTED THAT HE HAD FALLEN ASLEEP ON THE COUCH AND DID NOT HEAR ANY ALERTS FROM THE INSULIN PUMP. HE STATED THAT A FRIEND FOUND HIM AND CALLED 911. HE ADVISED THAT THERE HAD NOT BEEN ANY MALFUNCTION WITH THE DEVICE, STATING THAT IT WAS A MALFUNCTION ON HIS PART. EMERGENCY MEDICAL SERVICES TREATED HIM AT HIS HOME. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723743 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention