BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4132306 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31063
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS. NO OFF NO POWER ANOMALY WAS NOTED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND A STAINED END CAP STICKER.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP TURNS OFF WITHOUT WARNING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 175 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612694 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1