BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4083113 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21526
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    June 25, 2014
    Report Date
    August 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5. 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 HE EXPERIENCED LOW BLOOD GLUCOSE OF 50 MG/DL, TREATED BY EATING HONEY. CUSTOMER ALSO REPORTED THE INSULIN PUMP WAS NOT WORKING QUITE RIGHT THAT IT KEPT GIVING HIM HIGH NUMBERS. CUSTOMER MENTIONED 317 AND 279 MG/DL. CUSTOMER STATED HE WAS TRYING TO GIVE HIMSELF FIVE UNITS OF INSULIN AND GAVE HIMSELF 50 UNITS BY MANUAL INJECTION. CUSTOMER OVER DELIVERING INSULIN WAS THE CAUSE OF THE LOW BLOOD GLUCOSE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560767 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR