BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4033214 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-97659
    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
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. WE WERE UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO BLANK DISPLAY ANOMALY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LIQUID CRYSTAL DISPLAY WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE. WE WERE UNABLE TO VERIFY VIBRATE ANOMALY DUE TO THE BLANK DISPLAY.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXPOSING HIS INSULIN PUMP TO MOISTURE. THE CUSTOMER STATED THE INSULIN PUMP WON'T TURN ON AND ONLY VIBRATES. THE CUSTOMER ALSO STATED THERE WAS FLUID UNDER THE LCD DISPLAY. THE CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514688 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWL

    Patients

    Seq Age Sex Outcome Treatment
    1