BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-551NAB

    MDR report key: 7881592 · Received September 17, 2018

    Report

    Report Number
    2032227-2018-29012
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    August 11, 2018
    Report Date
    September 17, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200 TO 400 MG/DL. CUSTOMER ALSO HAD BLOOD GLUCOSE LEVEL OF 160, 358 AND 348 MG/DL. CUSTOMER REPORTS THEY HAD CONTACTED THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER WAS DECLINED TO TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS INJECTED INSULIN WITH NEEDLE. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721825 530G INSULIN PUMP MMT-551NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB A4551NABJ 00643169503625

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other FRN MODEL UNKNOWN UNOMEDICAL - INFUSION SET