BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8665680 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-11092
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 30, 2019
    Report Date
    October 25, 2019
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED WITH A MISSING DISPLAY WINDOW OR COVER, CRACKED BATTERY TUBE THREADS, CRACKED CASE-CORNER OF BELT CLIP RAILS. DEVICE PASSED THE DISPLACEMENT TEST. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 530 MG/DL. THE CUSTOMER DECLINED THE TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH THE MANUAL INJECTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458777 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG2442V 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other FRN-UNK-RSVR, UNOMED INF SET