BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4130552 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-95970
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TEST. NO MOTOR ERROR ALARM NOTED. MOTOR PASSED THE MOTOR TEST. INSULIN PUMP HAD A BUTTON ERROR ALARM DUE TO MOISTURE DAMAGE KEYPAD TRACES. MOISTURE DAMAGE FOUND ON LCD BOARDS. INSULIN PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. NO UNEXPECTED FAILED BATTERY TEST ALARM NOTED. INSULIN PUMP RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, RESERVOIR TUBE RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT NEAR BATTERY TUBE AND MINOR SCRATCHES ON DISPLAY 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 HER SON HAD GOTTEN INTO THE POOL WITH HIS INSULIN PUMP, CAUSING IT TO NOT WORK. THE SON'S BLOOD GLUCOSE WAS 182 MG/DL. CUSTOMER'S FATHER ALSO REPORTED A BUTTON ERROR ALARM AND FAILED BATTERY TEST. TROUBLESHOOTING DID NOT OCCUR BECAUSE THE SON WAS NOT THERE. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609080 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR