BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2250047 · Received September 9, 2011

    Report

    Report Number
    2032227-2011-02285
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 29, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. 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

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE INSULIN PUMP WOULD NOT REWIND, SO HE MANUALLY PUSHED ON THE PISTON WHILE HE WAS CONNECTED, AND DELIVERED A FULL 300 UNITS OF INSULIN INTO HIS BODY. THE CUSTOMER HAD TO GO TO THE HOSPITAL AFTER INJECTING SUCH A LARGE AMOUNT OF INSULIN. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE DISPLACEMENT AND SELF TESTS. 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 59 YR Hospitalization