BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5101868 · Received September 24, 2015

    Report

    Report Number
    2032227-2015-48477
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THEIR BLOOD GLUCOSE ROSE TO 433 MG/DL. THE CUSTOMER TREATED THEIR HIGH WITH THE INSULIN PUMP AND WATER. THE CUSTOMER WAS ABLE TO LOWER THEIR BLOOD GLUCOSE TO AROUND 200 MG/DL. CUSTOMER ALSO REPORTED ADHESIVE ISSUES WITH THEIR INFUSION SET. TROUBLESHOOTING WAS NOT COMPLETED FOR THE ADHESIVE ISSUE. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THEIR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631120 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other