BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4033541 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-96942
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    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 ALARMED FOR A BUTTON ERROR AND HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. IT WAS NOTED THAT THE ALARM PERSISTED EVEN AFTER A BATTERY CHANGE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513149 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1