BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4221604 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46569
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. HOWEVER, NO BUTTON ERROR ALARM WAS OBSERVED DURING TESTING. A CRACKED RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW NOTED.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP THAT THEY WERE UNABLE TO CLEAR. CUSTOMER STATED THAT THE INSULIN PUMP HAS BEEN BUMPED. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 136 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702246 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR