BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132154 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31022
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WENT THROUGH A PACK OF TEN BATTERIES, AFTER RECEIVING A BATTERY OUT LIMIT ALARM ON HER INSULIN PUMP, DURING NORMAL USE. THE CUSTOMER'S BLOOD GLUCOSE WAS 146 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE BASAL RATES WERE ACCURATE. THE CUSTOMER STATED THE BATTERIES WERE NOT OUT OF THE INSULIN PUMP GREATER THAN THE DURATION IT ALLOWS FOR. AFTER CLEARING THE ALARM, THE CUSTOMER WAS INSTRUCTED TO INSERT A NEW BATTERY IN LESS THAN A MINUTE. THE INSULIN PUMP DID NOT ALARM. THE INSULIN PUMP SHOWED A FULL BATTERY AND THEN THE DISPLAY WENT BLANK. THE BATTERY WAS REPLACED AND THE DISPLAY RETURNED. TROUBLESHOOTING WAS PERFORMED FOR A FAILED BATTERY TEST. THE ISSUE WAS RESOLVED WITH A NEW BATTERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612479 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR