BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2090102 · Received May 5, 2011

    Report

    Report Number
    2032227-2011-01172
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 30, 2011
    Report Date
    April 30, 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

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE CALLED TO REPORT A BUTTON ERROR ALARM THAT SHE COULD NOT CLEAR DUE TO UNRESPONSIVE BUTTONS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. AT THE TIME OF THE CALL, THE CUSTOMER'S BLOOD GLUCOSE READING WAS 400 MG/DL. THE WIFE STATED THAT THE CUSTOMER HAD NO BACK UP PAIN, AND WOULD BE TAKING THE CUSTOMER TO THE HOSPITAL FOR TREATMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization