BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142891 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-81879
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 38 MG/DL. THE CUSTOMER STATED THAT SHE WENT OUT TO DINE AND WHILE WAITING IN THE CAR FOR HER HUSBAND SHE STARTED TO SHAKE. THE CUSTOMER STATED THAT HER HUSBAND TRIED TO CHECK HER BLOOD GLUCOSE. THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS TAKEN TO THE HOSPITAL. TROUBLESHOOTING WAS DECLINED, AND THE CUSTOMER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFO WAS PROVIDED.

    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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization