BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212135 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44877
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP AND A CRACKED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE A DAMAGED INSULIN PUMP. CUSTOMER STATES INSULIN PUMP FELL, WHICH CAUSED A CRACK ON DISPLAY SCREEN AND BODY OF PUMP. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694157 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR