BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2863166 · Received December 10, 2012

    Report

    Report Number
    2032227-2012-07964
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY TESTS. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BASALS AND BOLUS PROFILES AND MONITORED. ALL BASAL AND BOLUS PROFILES DELIVERED PROPERLY AND CORRECTLY RECORDED IN THE HISTORY FILE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DKA. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 576 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT ON SEVERAL OCCASIONS THE INSULIN PUMP DID NOT DELIVER ANY INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization