BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4862368 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19851
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED FOR 24 HOURS, NO BLANK DISPLAY NOTED. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. THE INSULIN PUMP PASSED SELF-TEST. NO ISOLATION TAPE DAMAGE NOTED ON LCD BOARD. THE INSULIN PUMP WAS RECEIVED MISSING SEGMENT DUE TO CRACKED ZEBRA CONNECTOR ON LCD BOARD. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, AND CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE. NO STRIPPED BATTERY CAP COIN SLOT 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. DURING TROUBLESHOOTING, THE CUSTOMER CONFIRMED THAT THE BATTERY CAP WAS STRIPPED. THE CUSTOMER STATED THAT THIS DAMAGE OCCURRED OVER TIME WITH USE. BLOOD GLUCOSE LEVEL WAS 336 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405177 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR