BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4120019 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29439
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 THAT THE CUSTOMER HAD EMERGENCY ROOM VISIT DUE TO HIGH BLOOD GLUCOSE. NO BLOOD GLUCOSE READING PROVIDED. CUSTOMER STATED THAT THE BLOOD GLUCOSE WAS GOING HIGH AND DID NOT COME DOWN. CUSTOMER CHANGED THE SIRE AND IT DID NOT MAKE ANY DIFFERENCE. CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE EMERGENCY ROOM VISIT. CUSTOMER DECLINED TO TROUBLESHOOT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597811 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization