BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4862460 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19946
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE AND PROTRUDED DRIVE SUPPORT DISK. THE INSULIN PUMP HAD A CRACKED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT AND A STAINED END CAP STICKER.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WOULD NOT COMPLETE THE FILL TUBING PROCESS DURING A SET CHANGE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 252 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407488 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1