BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3920867 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86534
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 CALLER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 40 MG/DL. THE HUSBAND NOTICED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE SO HE GAVE HER GRAPES, WHICH DID NOT HELP. THEN, THE HUSBAND GAVE GLUCAGON SHOT, WHICH ALSO DID NOT HELP. THE HUSBAND CHECKED THE RESERVOIR AND NOTICED THAT IT WAS EMPTY, SO HE DROVE THE CUSTOMER TO THE EMERGENCY ROOM, WHERE THE CUSTOMER WAS GIVEN SYRINGES AND D50. THE CUSTOMER BELIEVES THAT THEY TOOK THE ENTIRE 100 UNITS OF INSULIN AT ONCE. TROUBLESHOOTING WAS PERFORMED ON THE INSULIN PUMP AND IT PASSED ALL FUNCTIONAL TESTS. THE DRIVE SUPPORT CAP WAS RECESSED. THE DATE WAS PROGRAMMED INCORRECTLY; IT WAS OFF BY ONE DAY. ALSO, THE RESERVOIR SHOWED LESS INSULIN THAN WHAT WAS SHOWN ON THE STATUS SCREEN OF THE DEVICE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398275 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization