BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751NAL

    MDR report key: 10669075 · Received October 13, 2020

    Report

    Report Number
    2032227-2020-190019
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    September 7, 2019
    Report Date
    October 13, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169503694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 48 MG/DL. THE CUSTOMER STATED DECLINED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED INF SET, OZO-MMT-7008-SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137050 530G INSULIN PUMP MMT-751NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL A4751NALJ 000000643169503694

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR