BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233581 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48728
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED DURING VISUAL INSPECTION. THE DEVICE WAS MONITORED. ALL OPERATING CURRENTS TESTED WITHIN SPECIFIC RANGE. NO BLANK DISPLAY NOTED.

    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 CUSTOMER RECEIVED AN ALARM AND HAD A BLANK SCREEN DISPLAY. AFTER SEVERAL BATTERY CHANGES, SCREEN DISPLAY DID NOT RETURN. INSULIN PUMP WOULD BE REPLACED. CUSTOMER'S BLOOD GLUCOSE WAS 85 MG/DL. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714766 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1