BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2915829 · Received January 15, 2013

    Report

    Report Number
    2032227-2013-00105
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CALLED TO REPORT THAT SHE HAS BEEN EXPERIENCING BLOOD GLUCOSE LEVELS AS LOW AS 39 MG/DL RECENTLY. THE CUSTOMER STATED THAT HER HCP HAS ADJUSTED THE INSULIN PUMP SETTINGS, BUT SHE CONTINUES TO EXPERIENCE LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS CONCERNED THAT HER INSULIN PUMP MAY BE OVER DELIVERING. ATTEMPTED TO TROUBLESHOOT WITH THE CUSTOMER, BUT THE CALL WAS DROPPED. CALLED THE CUSTOMER BACK BUT THERE WAS NO ANSWER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22376 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR