BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3982318 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06169
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    January 16, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PUMP RECEIVED WITH ALARM FOLLOWED BY ALARM AFTER BATTERY INSTALLATION, PROBLEM ISOLATED TO MOTHER BOARD. UNABLE TO PERFORM ANY TESTS DUE TO ALARM. PUMP RECEIVED WITH CORRODED BATTERY TUBE, CRACKED RESERVOIR TUBE LIP, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED ON DISPLAY WINDOW, STAINED ADDRESS/SERIAL NUMBER LABEL AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS TRYING TO TURN OFF THE INSULIN PUMP AND RECEIVE AN ERROR ALARM. BLOOD GLUCOSE 87 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457315 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR