BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3990395 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91061
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, A BROKEN BELT CLIP SLOT, AND A CRACKED RESERVOIR TUBE LIP. NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC ASSEMBLY. NO UNEXPECTED VIBRATING, BLANK DISPLAY OR CONSTANT TONE ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS EXPOSED TO WATER. THE CUSTOMER WAS WASHING A CAR, WHICH EXPOSED THE INSULIN PUMP TO MOISTURE. THE CUSTOMER'S FATHER STATED THAT THE INSULIN PUMP WAS VIBRATING WITHOUT AN ALARM OR ALERT AND THAT THE DISPLAY WENT BLANK IMMEDIATELY AFTER THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE CUSTOMER'S FATHER ALSO MENTIONED THAT A CONSTANT TONE WAS OCCURRING. THE CUSTOMER'S BLOOD GLUCOSE WAS 142 MG/DL AT THE TIME THE ISSUE WAS REPORTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464859 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB A7723NABJ

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR