BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3920840 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86531
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    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 THAT THE PARAMEDICS HAD TO BE CALLED BECAUSE SHE HAD LOW BLOOD GLUCOSE OF 26 MG/DL. SHE STATED THAT SHE HAD A FEVER DUE TO THE LOW BLOOD GLUCOSE AND BELIEVES THAT THE INCIDENT WAS DUE TO CHANGING HORMONES, SINCE SHE JUST HAD A BABY. THE CUSTOMER WAS HOSPITALIZED FOR THREE DAYS AND WAS WEARING THE INSULIN PUMP WHILE IN THE HOSPITAL. THE CUSTOMER WAS OFFERED TO PERFORM TROUBLESHOOTING ON THE DEVICE BUT SHE DECLINED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398396 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization