BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103364 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25207
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    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 WAS RECEIVED WITH LOOSE AND SLANTED DRIVE SUPPORT DISK NOTED. THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES NOTED. MOISTURE DAMAGE NOTED ON MOTOR HOME SWITCH CORRODED AND VIBRATOR MOTOR ASSEMBLY AND SEVERELY CORRODED BATTERY TUBE NOTED. MOISTURE DAMAGE WAS ALSO NOTED ON ALL ELECTRONIC ASSEMBLIES. NO UNEXPECTED BUTTON ERROR ALARMS NOTED. THE INSULIN PUMP HAS MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND STAINED END CAP STICKER. NO MISSING DOME LABEL STICKER NOTED, HOWEVER MISSING ADDRESS SERIAL NUMBER LABEL NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NO LONGER WORKING PROPERLY AND THE DISPLAY COULD NOT BE READ DUE TO CONDENSATION. CUSTOMER REPORTED REPLACING THE BATTERY AND RECEIVING A BUTTON ERROR ALARM. CUSTOMER STATED THAT HE FELL INTO A SWIMMING POOL WHILE WEARING THE INSULIN PUMP. BLOOD GLUCOSE LEVEL WAS 220 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584611 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR