BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3100685 · Received May 8, 2013

    Report

    Report Number
    2032227-2013-01760
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW CORNER, SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INSULIN PUMP IS ALARMING PRIME ALARM. THE DRIVES SUPPORT DISK IS PROTRUDED. ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP. ADVISED THAT INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200775 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR