BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4111450 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27611
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

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

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS AND BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP IS ALARMED BUTTON ERROR AND CANNOT BE CLEARED. CUSTOMER IS CURRENTLY TREATING WITH INSULIN INJECTIONS. BLOOD GLUCOSE VALUE IS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590599 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723PNAH A000169651

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR