BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 7800462 · Received August 21, 2018

    Report

    Report Number
    2032227-2018-15394
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    April 16, 2017
    Report Date
    August 21, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    CUSTOMER REPORTED VIA PHONE CALL HIS SUGARS WAS UP TO 400MG/DL . THEY TOOK IT OUT AND HAVEN'T ATTEMPTED TO CHANGE IT. CUSTOMER REPORTS BLOOD AT SITE. CUSTOMER IS ON 80MG ASPIRIN. CUSTOMER STATES THE SITE IS NOT ACTIVELY BLEEDING. CUSTOMER STATES SENSOR WAS NOT TUGGED OR PULLED ON AFTER INSERTION. THE CUSTOMER REPORTS NO SYMPTOMS. CUSTOMER TREATED WITH ORANGE JUICE AND PEPSI. WENT UP TO 205MG/DL AND THEN 256MG/DL. CUSTOMER ALSO TREATED WITH A 7 UNIT BOLUS. TURNED DOWN BASAL. THEN IT WENT DOWN TO 98MG/DL. 5 HOURS LATER WENT DOWN TO 58MG/DL. AND TREATED WITH ORANGE JUICE AND A PBJ SANDWICH. UNABLE TO TROUBLESHOOT DUE TO CUSTOMER NOT HAVING THE INSULIN PUMP WITH THEM. PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643131 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG1N6DW 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other FRN RESERVOIRUNOMEDICAL INFUSION SET