BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183506 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40244
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE IN EARLY (B)(6) 2014, BUT DID NOT HAVE ANY DETAILS ON THEM ABOUT THE INCIDENT. CUSTOMER'S PARENT STATED THAT THE CUSTOMER'S DAD DID NOT INSERT THE INFUSION SET CORRECTLY AND IT RESULTED IN A HIGH BLOOD GLUCOSE LEVEL AND HOSPITALIZATION. CUSTOMER CALLED IN FOR A BELT CLIP AND MENTIONED THE HOSPITALIZATION DURING THE OUTREACH QUESTIONING. CUSTOMER WAS IN A RUSH TO GET OFF THE PHONE DUE TO A FAMILY OUTING. CUSTOMER'S PARENT STATED THAT IT WAS USER ERROR AND NOT RELATED TO THE PUMP FUNCTIONING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664126 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization