BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 14871636 · Received June 30, 2022

    Report

    Report Number
    2032227-2022-252367
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    January 26, 2018
    Report Date
    June 30, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION/REMOVAL NUMBER: 2032227-060322-002-C. (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. 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."

    Description of Event or Problem · 0

    COMPLAINTS TEXT (B)(6) 2018 09:52:09 ERP_RFC_USER RELATED SVN (B)(4). COMPLAINTS TEXT (B)(6) 2018 09:51:02 WOODSJ6 CORRECTION...THIS IS FOR A BATTERY CAP NOT A BELT CLIP SHIP OUT A BATTERY CAP MMT-1527 . 1 RTN : NOTHING COMPLAINTS TEXT (B)(6) 2018 09:47:06 WOODSJ6 INITIAL NOTES: I LOST THE METAL PEACE IN THE BATTERY CAPINQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: IT WENT FLYING AS I WENT TO CHANGE THE BATTERY WHEN I TOOK OF THE BATTERY CAP.. CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: SHIP OUT TO THE CUSTOMER A BATTERY CAP ACC-1599 ADDITIONAL NOTES: ASST CUSTOMER : SHIP TO 1101 MIDLAND AVE APT 329 YONKERS NY 10708 CALL 1 (718) 219-9907... I PUT SOME FOIAL UP INTO IT TO HAVE I WORKING I DID OFER TO T/S FOR THAT BATTERY CAP ISSUE BUT THE CUSTOMER DECLINED SHIP: 1 BATTERY CAP, ACC-1599 / RETURN: NOTHING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579422 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG1U2T0 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown