BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4895367 · Received July 7, 2015

    Report

    Report Number
    2032227-2015-21258
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    April 16, 2015
    Report Date
    June 16, 2015
    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

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

    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

    IT WAS REPORTED VIA PHONE CALL, THAT THE ACT BUTTON ON THE INSULIN PUMP WAS UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE INSULIN PUMP HAS CRACKS TO THE CASE. TROUBLESHOOTING OCCURRED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439014 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR