BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7818218 · Received August 27, 2018

    Report

    Report Number
    2032227-2018-18862
    Event Type
    Injury
    Date Received
    August 27, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 27, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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

    COMPLAINTS TEXT (B)(6) 2018 20:18:13 ERP_RFC_USER RELATED (B)(4); COMPLAINTS TEXT (B)(6) 2018 20:18:04 (B)(4) INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: CUSTOMER STATES THAT HE RECEIVED A BRAND NEW INSULIN PUMP. CUSTOMER STATES THAT HE HAS BEEN ON THE PUMP FOR TWO DAYS. CUSTOMER STATES THAT IT IS ASKING FOR A CALIBRATION. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: AVD CUST THAT HE WONT BE ABLE TO CALIBRATE WITH THAT HIGH OF A BG. ADV CUSTOMER THAT HIS BG 'S NEED TO BE STABLE BEFORE CALIBRATING. ADDITIONAL NOTES: CUSTOMER STATES THAT HE HAS BEEN RUNNING HIGHER AND WOULD BE CALLING HIS HCP TOMORROW BECAUSE HIS SETTINGS NEED TO BE ADJUSTED. CUSTOMER DECLINED T/S STATES HE WOULD BE GIVING A CORRECTION DOSE. SHIP: NOTHING / RETURN: NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661031 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2JXKR 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other