BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4143420 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30137
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSE 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

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS. NO EXACT BLOOD GLUCOSE LEVELS WERE PROVIDED. THE CUSTOMER WAS REPORTEDLY TREATED BY EMERGENCY MEDICAL SERVICES THAT PROVIDED A GLUCAGON SHOT TO THE CUSTOMER. THE CUSTOMER REPORTED THAT THE SENSOR OF THE INSULIN PUMP SHOWED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER ERRONEOUSLY THOUGHT THAT HE ACTUALLY HAD HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER TREATED WITH A BOLUS FROM THE INSULIN PUMP IN ERROR. THE CUSTOMER HAS NOT WORN THE SENSOR OF THE INSULIN PUMP EVER SINCE THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603554 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR