BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123633 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29779
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, BROKEN BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, MISSING END CAP STICKER AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. MOTOR ERROR ALARMED DURING BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. UNABLE TO CONFIRM ALARMS DUE TO MOTOR ERROR ALARMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED THE SAME ERROR MORE THAN ONCE AND THE INSULIN PUMP'S SENSOR COULD NO LONGER READ THE RESERVOIR STATUS. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600392 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554WWP

    Patients

    Seq Age Sex Outcome Treatment
    1