BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4242793 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-49921
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP BUTTONS ALL RESPONDED PROPERLY. HOWEVER, MOISTURE DAMAGE WAS NOTED AT THE KEYPAD TRACES. THE INSULIN PUMP PASSED THE BASIC OCCLUSION TEST AND THE DISPLACEMENT TEST. HOWEVER, THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SEVERE SCRATCHES ON THE DISPLAY WINDOW AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD AN UNRESPONSIVE KEYPAD. THE BLOOD GLUCOSE READING WAS 54 MG/DL. ADVISED TO CONDUCT TROUBLESHOOTING FOR THE LOW BLOOD GLUCOSE, BUT THE CUSTOMER DECLINED. NO SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES WERE OBSERVED. ADVISED DISCONTINUATION OF THE INSULIN PUMP AND REVERT TO THEIR BACK-UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725574 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR