BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4792059 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58823
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NO ACT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE WINDOW.

    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'S MOTHER REPORTED VIA PHONE, THE INSULIN PUMP HAD ALARMED BUTTON ERROR. CUSTOMER WEARS THE DEVICE IN HER BRA AND IT FACES THE SKIN. CUSTOMER'S BLOOD GLUCOSE WAS 111 MG/DL. CUSTOMER'S MOTHER DOESN'T RECALL ANY SIGNIFICANT EVENT WHICH MAY HAVE CAUSED THE DEVICE TO ALARM. CUSTOMER'S MOTHER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND DEVICE NEED TO BE REPLACED. CUSTOMER'S MOTHER AGREED TO RETURN THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334446 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 14 YR