BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4032717 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-96700
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT ALL THE OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED BATTERY OUT LIMIT ALARM NOTED. HOWEVER, THE DEVICE HAD INTERMITTENT BUTTON RESPONSE DURING TESTING DUE TO CORRODED KEYPAD TRACES. THE UNIT WAS RECEIVED WITH CRACKED CASE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, DEEP CRACKED ON THE RESERVOIR TUBE, BROKEN RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING BATTERY OUT LIMIT ALARM. THE CUSTOMER COULD NOT TROUBLESHOOT BECAUSE THE KEYPAD WAS NOT WORKING. THE CUSTOMER ALSO STATED HE WAS UNABLE TO GIVE HIMSELF A BOLUS DELIVERY BECAUSE THE KEYPAD KEPT SCROLLING. CUSTOMER'S BLOOD GLUCOSE WAS 185 MG/DL. THE CUSTOMER STATED HE MAY HAVE GOTTEN WATER ON HIS INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512698 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR