BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4760794 · Received May 8, 2015

    Report

    Report Number
    3004209178-2015-54511
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INDICATING THAT THE INSULIN PUMP ALARM WEAK BATTERY AND BATTERY OUT LIMIT. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN MG/DL. AFTER TROUBLESHOOTING WAS DONE, CUSTOMER WAS ADVISED THAT WE WILL SEND A REPLACEMENT BATTERY CAP AND MONITOR THE INSULIN PUMP. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR LOW BATTERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303931 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR