BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 11114739 · Received January 4, 2021

    Report

    Report Number
    2032227-2021-100440
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 29, 2020
    Report Date
    February 28, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PASSED FUNCTIONAL TESTING INCLUDING DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENTS, ACTIVE CURRENTS AND SELFTEST. DEVICE COMMUNICATED PROPERLY WITH TEST GUARDIAN LINK TRANSMITTER. NO CHANGE SENSOR ALERT NOTED. DEVICE RECEIVED WITH SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP DOES LOCK PROPERLY. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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 WERE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED INFUSION SET SITE WAS LEAKING. ALSO REPORTED CHANGE SENSOR AND SENSOR UPDATING ERROR. IT WAS UNKNOWN THAT THE AUTO MODE FEATURE WAS ACTIVE AT TIME OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3513 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3ZE8C 000000763000283520

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other FRN-UNK-RSVR, UNOMED SET, OZP-MMT-7020-SNR| FRN-UNK-RSVR, UNOMED SET, OZP-MMT-7020-SNR