BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5171039 · Received October 23, 2015

    Report

    Report Number
    2032227-2015-59105
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    October 4, 2015
    Report Date
    October 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD DAMAGE. CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. THE CUSTOMER STATED THAT THE END CAP SEEMS LOOSE. THE CUSTOMER STATED THAT THE END CAP GETS BANGED FROM TIME TO TIME, FALLS OUT OF THE POUCH. THE CUSTOMER STATED THAT THE DRIVE SUPPORT IS FLUSH. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACKUP PLAN. CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701277 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1