BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4050094 · Received August 30, 2014

    Report

    Report Number
    2032227-2014-14626
    Event Type
    Malfunction
    Date Received
    August 30, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE WINDOW WERE NOTED DURING THE VISUAL INSPECTION. NO BUTTON ERROR ALARMS WERE NOTED. THE INSULIN PUMP HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE WAS NOTED IN THE BATTERY TUBE OR BATTERY CAP. THE INSULIN PUMP HAD MOISTURE DAMAGE ON THE DISPLAY BOARD AND MOTOR ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. IT WAS FOUND THAT THERE WAS A POSSIBLE LEAK IN THE BATTERY COMPARTMENT. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531015 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR