BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4090317 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23183
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS EXPERIENCING HIGH BLOOD SUGAR UP TO 555 MG/DL. THE CUSTOMER STATED HER BLOOD GLUCOSE HAD GONE DOWN TO 345 MG/DL AT THE TIME OF REPORTING, FOLLOWING A 410 MG/DL BLOOD GLUCOSE, AFTER A BOLUS WITH THE INSULIN PUMP. THE CUSTOMER STATED SHE DID NOT EXPERIENCE ANY SYMPTOMS OF HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR BUBBLES WERE FOUND. INSULIN DID EXIT THE TUBING DURING A MANUAL PRIME AND NO LEAKS WERE FOUND. SETTINGS AND HISTORY WERE FOUND TO BE CORRECT. A HIGH PRESSURE TEST WAS PERFORMED AND PASSED. UPON REMOVAL OF THE INFUSION SET, THE CANNULA WAS FOUND TO BE BENT BUT NOT OCCLUDED. THE INSERTION SITE WAS BLEEDING. THE CUSTOMER WAS INSTRUCTED TO APPLY PRESSURE WITH A TISSUE TO STOP BLEEDING, AND CHANGE OUT THE INFUSION SET, RESERVOIR AND INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568448 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR