BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2193387 · Received July 29, 2011

    Report

    Report Number
    2032227-2011-01876
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A CRACKED AND BLEEDING LIQUID CRYSTAL DISPLAY GLASS. UNABLE TO PERFORM FUNCTIONAL TESTS DUE TO THE CRACKED AND BLEEDING LIQUID CRYSTAL DISPLAY GLASS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS JUST RELEASED FROM THE HOSP DUE TO A STROKE. THE CUSTOMER DID NOT KNOW WHETHER OR NOT THE STROKE WAS RELATED TO HER DIABETES. THE CUSTOMER STATED THAT SHE PASSED OUT AND FELL ON THE INSULIN PUMP, CAUSING A CRACK IN THE MIDDLE OF THE SCREEN. 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 MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization