BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530 G INSULIN PUMP

    MDR report key: 4143418 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30134
    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
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS OF 33 MG/DL. THE CUSTOMER WAS HOSPITALIZED. THE CUSTOMER WAS TREATED WITH A TUBE OF D-50. THE HIPAA GUARDIAN OF THE CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH THE SETTINGS OF THE INSULIN PUMP GIVING THE CUSTOMER TOO MUCH INSULIN. THE GUARDIAN OF THE CUSTOMER REPORTED THAT SETTINGS FOR THE INSULIN PUMP HAVE BEEN ADJUSTED AND THEY HAVE NOT HAD ANY FURTHER ISSUES AFTERWARDS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603624 530 G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization