BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3093723 · Received May 6, 2013

    Report

    Report Number
    2032227-2013-01678
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    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

    CUSTOMER REPORTED EMERGENCY ROOM VISIT DUE TO HIGH BLOOD GLUCOSE. THE READING AT THE TIME OF THE EVENT 496 MG/DL. CUSTOMER TREATED FOR DIABETIC KETOACIDOSIS. CUSTOMER EXPERIENCED DEHYDRATION, DRY MOUTH, NAUSEA, AND DIZZYNESS. CUSTOMER'S BLOOD GLUCOSE DROPPED TO 76 MG/DL. WHEN SHE ARRIVED AT HOSPITAL, CUSTOMER HAD PREVIOUSLY TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT RESERVOIR HAD LEAKED INTO INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196599 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization