BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3924379 · Received July 9, 2014

    Report

    Report Number
    2032227-2014-03485
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO FLATTENED DOWN ARROW BUTTON. NO DISPLAY RAMPING ON ITS OWN ANOMALY NOTED. INSULIN PUMP RECEIVED WITH CRACKED BATTERY TUBE THREADS AND RESERVOIR TUBE LIP AND MINOR SCRATCHES ON LCD WINDOW.

    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. THE DEVICE WILL BE RETURN FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED ABOUT A MONTH AGO DUE TO LOW BLOOD GLUCOSE AND ALLERGIC REACTION TO ANTS. CUSTOMER STATED THAT HER INSULIN PUMP KEYPAD IS STICKING MAKING THE NUMBERS SCROLL UP AND DOWN. CUSTOMER STATED THAT SHE PROGRAMMED 10 UNITS OF INSULIN AND THE NUMBER SCROLL UP TO 100 UNITS CAUSING THE LOW BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400982 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization