BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 15038799 · Received July 18, 2022

    Report

    Report Number
    2032227-2022-288375
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    August 22, 2018
    Report Date
    July 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169782396
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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

    0N (B)(6) 2018 21:37:22 PST ICE BATCH USER (BATCH_ICE) PHONE (B)(6) COMPLAINT: (B)(4) COMPLAINT STATUS: IN PROCESS MDT INITIAL CONTACT: MELBA POTTER TAKEN BY: PATELS39 POTTEM3 (B)(6) 2018 FATHER STATED ARE HAVING A PROBLEM WITH THE PUMP. IT KEPT COMING UP WITH INSERT NEW BATTERY. THEY HAVE TRIED MULTIPLE NEW BATTERIES AND THEY LOST THE BATTERY CAP. CUST DIDN'T CHECK BG AND WEIGHS 220 POUNDS. FATHER STATED THERE IS NO PHYSICAL DAMAGE TO THE PUMP. ADV REVERTING TO A BACKUP PLAN. EXPL WE WILL SUBMIT THE REQUEST TO SEND A REPLACEMENT BATTERY CAP. ADV CALLING BACK IF THE BATTERY CAP DOESN'T SOLVE THE ISSUE. SHIP: 1 ACC-1527 / RETURN: NOTHING (B)(6) 2018 12:45 PM PATELS39: SO # (B)(4) GARZAR6 (B)(6) 2018 CUSTOMERS FATHER CALLED BACK TO INQUIRE ABOUT THE FOLLOWING: HE WENT TO CHANGE THE BATTERY AND IT KEPT SENDING MESSAGES ON THE BOTTOM SIDE OF THE BATTERY CAP THE METAL PIECE IS MISSING, I JUST WANTED TO KNOW IF IT SHOULD BE THERE.INFORMED CUSTOMER THAT THE METAL PIECE IS WHAT MAKES CONTACT WITH THE BATTERY. INFORMED CUSTOMER THAT THE LOCAL OFFICE WOULD REACH OUT TO HIM TO INFORM HIM WHEN THE REPLACEMENT BATTERY CAP WOULD ARRIVE. NO FURTHER ASSISTANCE REQUIRED. COUNTRY: CANADA CITY: (B)(6) ZIP: (B)(4) INPUT DATE: (B)(6) 2018 WARRANTY START: (B)(6) 2017 WARRANTY END: (B)(6) 2021 BATCH - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2508112 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG22UW2 00643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown