BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2940024 · Received February 1, 2013

    Report

    Report Number
    2032227-2013-00453
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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

    CUSTOMER REPORTED THAT THE PARAMEDICS WERE CALLED TO ASSIST HIM DUE LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 22 MG/DL AT THE TIME THE PARAMEDICS ARRIVED. CUSTOMER STATED THAT HIS WIFE TOOK HIM TO THE EMERGENCY ROOM LATER THAT DAY DUE TO INFECTION ON THE BACK OF NECK. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44533 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization