BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103331 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25189
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 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
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH A DETACHED END CAP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, AND A CRACKED RESERVOIR TUBE LIP. UNABLE TO VERIFY ANY ALARMS DUE TO THE DETATCHED END CAP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED DURING THE MANUAL PRIME. CUSTOMER STATED THAT THE INSULIN PUMP SHUT DOWN AND REBOOTED ITSELF. CUSTOMER THEN MENTIONED THAT THE INSULIN PUMP COUNTED TO SIX AND CAME BACK. CUSTOMER ALSO REPORTED THAT INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME AND CONTINUED TO DRIP EVEN AFTER THE MOTOR STOPS. CUSTOMER WAS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE DRIVE SUPPORT CAP WAS NOTED TO BE NORMAL. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 177 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585021 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR