BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4173680 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38321
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS FOR A DAY. THE BLOOD GLUCOSE READING REACHED AS LOW AS 35 MG/DL AND AS HIGH AS 305 MG/DL THAT DAY. THE CUSTOMER DISCONNECTED FROM THE INSULIN PUMP AND BEGAN USING A NEW INSULIN PUMP. UNABLE TO TROUBLESHOOT DUE TO THE CUSTOMER ALREADY HAVING DISCONNECTED. HE REPORTED THAT HIS BLOOD GLUCOSE LEVELS HAD BEEN STABILIZED WITH THE NEW INSULIN PUMP. THE MOST RECENT BLOOD GLUCOSE READING WAS 53 MG/DL, WHICH WAS TREATED FOR WITH FOOD. ADVISED THE CUSTOMER TO MONITOR THE BLOOD GLUCOSE LEVELS WITH THE NEW INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655041 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR