BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123479 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29700
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. PLEASE SEE MEDWATCH REPORT 2032227-2014-29630.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED MULTIPLE NO DELIVERY ALARMS AND HIGH BLOOD GLUCOSE OF UP TO 517 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE WAS AT 484 MG/DL WHEN SHE TRIED TO DELIVER A BOLUS EARLIER. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. SETTINGS AND HISTORY WERE FOUND TO BE CORRECT. THE CANNULA OF THE INFUSION SET WAS NOT BENT OR OCCLUDED. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN. THE INSERTION SITE WAS NOT SORE OR IRRITATED. THE NO DELIVERY ALARMS RECURRED AND THE CUSTOMER'S BLOOD GLUCOSE WAS 359 MG/DL. THE CUSTOMER STATED SHE HAD NOT TRIED ALL REMEDIES SUGGESTED AND WAS ADVISED TO DO SO TO PREVENT RECURRING ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600271 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR