BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7901201 · Received September 24, 2018

    Report

    Report Number
    2032227-2018-32396
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    September 1, 2018
    Report Date
    September 24, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 WHILE PRIMING THE INSULIN PUMP SHE NOTICED A BURNING FEELING AT HER SITE. THE CUSTOMER DISCOVERED THAT HER RESERVOIR WAS EMPTY. APPROXIMATELY 250 UNITS OF INSULIN WAS INJECTED INTO THE CUSTOMER. SHE CALLED THE ER AND THEY INSTRUCTED HER TO CHECK HER BLOOD GLUCOSE EVERY 15 MINUTES AND TO EAT PROTEIN. THE CUSTOMER'S MOST RECENT BLOOD GLUCOSE VALUE WAS 245 MG/DL. THE CUSTOMER WAS PURCHASING REGULAR SODA AT (B)(6). SHE WAS ADVISED TO VISIT THE ER BUT SHE INSISTED UPON CONTINUING TO CONSUME GLUCOSE AND CHECK HER BLOOD GLUCOSE. AN HOUR AFTER THE INITIAL PHONE CALL, THE CUSTOMER WAS CALLED BACK. HER BLOOD GLUCOSE WAS 111 MG/DL. SHE REPORTED THAT SHE CONSUMED MILK, COOKIES, AND A 20 OZ (B)(6). SINCE ARRIVING HOME, SHE HAD ALSO CONSUMED A LARGE GLASS OF ORANGE JUICE. SHE HAD A HALF GALLON OF JUICE IN HER POSSESSION AND HER BOYFRIEND WAS WATCHING OVER HER. OVER THE NEXT TWO HOURS, THE CUSTOMER WAS ABLE TO PREVENT HYPOGLYCEMIA; HOWEVER, SHE WAS TIRED AND TOOK A NAP. SHE WOKE UP AN HOUR AND A HALF LATER WITH A BLOOD GLUCOSE OF 47 MG/DL. THE CUSTOMER TREATED WITH A CANDY BAR, PEANUT BUTTER AND JELLY SANDWICH, AND SUGAR. HER BLOOD GLUCOSE INCREASED TO 80 MG/DL TEN MINUTES LATER, AND TO 112 MG/DL TWO MINUTES AFTER THAT. TROUBLESHOOTING DID NOT OCCUR. IT IS UNKNOWN IF THE AUTO MODE FEATURE WAS AUTOMATICALLY ADJUSTING INSULIN DELIVERY DURING THE INCIDENT. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS. UNOMEDICAL SET. FRN-MODEL UNKNOWN-RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744483 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2QBF8 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other FRN RESERVOIRUNOMEDICAL INF. SET