BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4141874 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33630
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 HE WAS HOSPITALIZED WITH LOW BLOOD GLUCOSE OF 22 MG/DL, AFTER HE WAS IN A VEHICULAR ACCIDENT IN WHICH HE WAS DRIVING. THE CUSTOMER STATED THE CAUSE OF THE LOW BLOOD GLUCOSE WAS THAT HE OVER-CORRECTED WITH A MANUAL INJECTION FOR A HIGH BLOOD GLUCOSE, DUE TO RECEIVING A NO DELIVERY ALARM ON THE INSULIN PUMP. THE CUSTOMER STATED THAT THE NO DELIVERY ALARM WAS RESOLVED BY A COMPLETE SET CHANGE. THE CUSTOMER STATED THAT HE HAD BEEN RECEIVING NO DELIVERY ALARMS SINCE 2009 ON VARIOUS INSULIN PUMPS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621726 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization