BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4110785 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27923
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE THREE SEPARATE OCCASIONS WHERE THE INSULIN PUMP WAS NOT DELIVERING INSULIN. THE CUSTOMER STATED THAT THE INFUSION SETS WERE NOT WORKING EACH TIME. THE CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING AS HE DID NOT FEEL WELL ENOUGH TO DO SO. SHE FURTHER STATED SHE WOKE UP TO A 400 MG/DL BLOOD SUGAR AND TREATED WITH THE INSULIN PUMP AND AN HOUR LATER, HER BLOOD GLUCOSE WAS 450 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589597 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR