BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4812949 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61667
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 VIA PHONE CALL THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE PRIME PROCESS AND BOLUS DELIVERY. THE CUSTOMER STATED THAT HE KEPT RECEIVING THE NO DELIVERY ALARMS SINCE THE DAY PRIOR. AT THE TIME OF THE CALL, THE CUSTOMER STATED THAT THE INSULIN PUMP WORKED AND DECLINED TO PROCEED WITH THE TROUBLESHOOT PROCEDURE. THE CUSTOMER'S BLOOD GLUCOSE WAS 247 MG/DL. THE CUSTOMER WAS ADVISED TO CALL BACK IF THE ALARM RECURRED IN ORDER TO PROCEED WITH THE TROUBLESHOOT PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355063 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR