BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2944561 · Received February 5, 2013

    Report

    Report Number
    2032227-2013-00457
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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

    THE CUSTOMER REPORTED THAT THE PROGRAMMING ON THE INSULIN PUMP WAS INCORRECT. THE CUSTOMER USES APIDRA, AND HE FEELS THAT THE INSULIN WAS NOT PROGRAMMED PROPERLY IN THE INSULIN PUMP. THE CUSTOMER STATED THAT APIDRA WORKS FASTER IN HIS BODY THAN HUMALOG OR NOVALOG. THE CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED IN ONE OCCASION DUE TO HIS LOW BLOOD GLUCOSE OF 37MG/DL, AND HE MENTIONED HAVING LOW BLOOD GLUCOSE FOR THE PAST FOUR MONTHS. THE CALLER STATED THAT THE INFUSION SET WAS CHANGED PRIOR TO HIS ADMISSION. HE ALSO STATED THAT HE DOES NOT USE THE BOLUS WIZARD AS HE DOES NOT TRUST, AND HE CALCULATES HIS OWN CORRECTIONS. TROUBLESHOOTING WAS DECLINED AS CUSTOMER DOES NOT FEEL THE INSULIN PUMP WAS MALFUNCTIONING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48645 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization