BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4760220 · Received May 8, 2015

    Report

    Report Number
    2032227-2015-14042
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    April 5, 2015
    Report Date
    April 14, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED DISPLAY WINDOW, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A SHIFTED AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HOSPITALIZATION. CUSTOMER REPORTED VIA PHONE CALL THAT THE BLOOD GLUCOSE READINGS WENT UP TO 805 MG/DL. CUSTOMER ALSO STATES THAT THERE IS AN ABSENCE OF A NO DELIVERY ALARM. CUSTOMER HAD AN ULCER ON THEIR FOOT; THEREFORE AN AMBULANCE BROUGHT A WHEEL CHAIR FOR HIM. CUSTOMER WAS THROWING UP ALL NIGHT. THE BLOOD GLUCOSE READINGS WERE FLUCTUATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303962 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR