BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 5296395 · Received December 14, 2015

    Report

    Report Number
    2032227-2015-74300
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Date of Event
    November 26, 2015
    Report Date
    November 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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'S MOTHER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN MG/DL. THE CUSTOMER STATED THAT THERE IS NO SIGNIFICANT EVENT LEADING TO THE KEYPAD ISSUE. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. THE MOTHER WOULD RATHER GET THE OOW LETTER AND NEW PUMP WITH NEW WARRANTY AND DECLINED THE PUMP REPLACEMENT, OOW LETTER WILL BE SENT SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823720 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1