BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123457 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-27199
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED A33 DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CASE CRACKED AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BELT CLIP SLOT, STAINED END CAP STICKER, RESERVOIR TUBE CRACKED AND STAINED ADDRESS SERIAL NUMBER LABEL.

    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 AN ALARMING INSULIN PUMP. THE BLOOD GLUCOSE READING IS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600092 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 113 YR