BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2004293 · Received February 22, 2011

    Report

    Report Number
    3004209178-2011-80466
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    PP980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    A LAWSUIT ALLEGES THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HEART PALPITATIONS, SHORTNESS OF BREATH, AND OTHER SYMPTOMS. THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM, WHERE IT WAS DISCOVERED THAT HIS BLOOD GLUCOSE WAS ELEVATED AND HE WAS IN EARLY DIABETIC KETOACIDOSIS. THE LAWSUIT CLAIMS THAT THE INSULIN PUMP AND INFUSION SET WERE CASUALLY LINKED TO THE EVENT. THE INFUSION SET IN USE WAS A MMT-397 QUICK-SET, LOT NUMBER 8200742. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization