BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAS PRDGM INSULIN PUMP

    MDR report key: 7912543 · Received September 26, 2018

    Report

    Report Number
    2032227-2018-33856
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    September 10, 2018
    Report Date
    September 26, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WENT TO THE EMERGENCY ROOM ON (B)(6) 2018 AT 10:14 PM DUE TO A BLOOD GLUCOSE LEVEL OF 596 MG/DL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 600 MG/DL. DURING THE CALL THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS BLURRY VISION, NO SYMPTOMS WERE REPORTED AT THE HOSPITAL. THE CUSTOMER WAS GIVEN INSULIN THROUGH INTRAVENOUS THERAPY AT THE HOSPITAL AND TREATED THE HIGH BLOOD GLUCOSE DURING THE CALL WITH A BOLUS DELIVERY. TROUBLESHOOTING WAS PROVIDED FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED NOT LETTING INSULIN EXIT BEFORE CONNECTING IT TO THEIR BODY, POSSIBLY CAUSING THE INSULIN TO NOT ENTER THE BODY PROPERLY. THE INSULIN PUMP WILL NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753273 NAS PRDGM INSULIN PUMP PUMP, INFUSION, INSULIN OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization