BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4090454 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23136
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER REPORTED THAT HE HAS BEEN HAVING PROBLEMS WITH HIS SENSORS AND INFUSION SETS NOT STICKING. CUSTOMER COMPLAINED ABOUT THE SENSORS FALLING OFF AND HE IS BLEEDING FROM IT. BLOOD GLUCOSE LEVEL IS 138 MG/DL. CUSTOMER DOES PERSPIRE HEAVILY DUE TO HIS WORK. CUSTOMER STATES HE IS USING SOAP AND WATER TO PREPARE THE SITE. CUSTOMER ALSO REPORTED THAT HE RECEIVED A NO DELIVERY ALARM ON THE INSULIN PUMP AND DELIVERED 3 INSULIN UNITS IT DIDN'T ALARM. CUSTOMER STATED THAT HIS BLOOD GLUCOSE WENT TO 600 MG/DL BECAUSE THE CANNULA ON THE INFUSION SET WAS BENT AND THE INSULIN PUMP DID NOT ALARM HIM. HIGH PRESSURE TEST WAS PERFORMED AND THE CUSTOMER STATED IT DID ALARM. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570029 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAL A2751NALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR