BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5981689 · Received September 27, 2016

    Report

    Report Number
    2032227-2016-24286
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    August 28, 2016
    Report Date
    August 28, 2016
    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

    THE UNIT RECEIVED WITH CRACKED AND BLEEDING LCD GLASS, BROKEN OFF CASING AT VIBRATOR MOTOR AREA AND DRIED MUD ON ALL ELECTRONIC ASSEMBLIES NOTED. THE UNIT WAS UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO LCD PHYSICAL DAMAGE. THERE WAS DRIED MUD ON THE VIBRATOR MOTOR ASSEMBLY. THERE WAS ALSO A MISSING DISPLAY WINDOW COVER, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS,CRACKED BELT CLIP SLOT AND LOOSE/PROTRUDED DRIVE SUPPORT DISK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP FELL OUT OF HER POCKET WHILE SHE WAS ON A THEME PARK RIDE. THE DEVICE LANDED IN MUD AND THE SCREEN WAS SHATTERED. THERE WERE MISSING PIECES TO THE DEVICE AS WELL. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 149 MG/DL. THE DRIVE SUPPORT CAP CASING WAS DAMAGED AND THE BATTERY WAS EXPOSED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS AND A REPLACEMENT DEVICE WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631989 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR