BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2121463 · Received June 7, 2011

    Report

    Report Number
    3004209178-2011-81693
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS REC'D WITH A BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BUTTON ERROR ALARM DURING NORMAL USE. THE CUSTOMER STATED THAT HE HAD TO GO TO THE HOSP FOR ASSISTANCE DUE TO THE ALARM. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. 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 17 YR Hospitalization