BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132041 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30894
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 23, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH THE INFUSION SET. CUSTOMER STATED THAT HE HAD GIVEN 2 UNITS OF INSULIN, WHICH WAS MORE THAN WHAT THE PUMP SAID. CUSTOMER ALSO STATED THAT HE RECEIVED A NO DELIVERY ALARM. CUSTOMER REPORTED THAT HE HAD A BLOOD GLUCOSE LEVEL OF 49 MG/DL AT 6:00AM. CUSTOMER INQUIRED ABOUT HER LOW AND HIGH ALARMS. CUSTOMER STATED THAT SHE HAD HIGH BLOOD GLUCOSE LEVELS A COUPLE OF WEEKS AGO. CUSTOMER STATED THAT SHE WILL MONITOR AND WILL CALL BACK TO TROUBLESHOOT THE PUMP IF NEEDED. CUSTOMER DOES NOT WANT TO TROUBLESHOOT AT THIS TIME. ON 09/01/14, CUSTOMER CHANGED THE INFUSION SET AND REPORTED THAT THE NO DELIVERY ALARM WAS RESOLVED BY THE SET CHANGE. CUSTOMER DOES NOT WANT TO RETURN THE SET FOR ANALYSIS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610371 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR