BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9858257 · Received March 19, 2020

    Report

    Report Number
    3004209178-2020-88681
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 19, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000190439
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WENT TO THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READINGS WERE 212 ,269, 243, 273 AND 300 MG/DL. THE CUSTOMER TREATED THE HIGH BLOOD GLUCOSE READINGS WITH BOLUSES AND ALSO WENT TO THE EMERGENCY ROOM. THE CUSTOMER ALSO STATED THAT THE RESERVOIR APPEARS TO BE INSERTED INTO THE PUMP COCKEYED, THE RIGHT SIDE IS FLAT BUT THE LEFT SIDE IS RAISED UP. TROUBLESHOOTING FOR THE CUSTOMER¿S HIGH BLOOD GLUCOSE WAS DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320882 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG2WCGD 00763000190439

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization FRN-RSVR, UNOMED SET