BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 12582205 · Received October 6, 2021

    Report

    Report Number
    2032227-2021-201655
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 30, 2021
    Report Date
    April 4, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. ON 09/30/2021 THE CUSTOMER REPORTED A CRACK ON THE BATTERY COMPARTMENT AND THE UNIT REJECTS BATTERIES. INSERTED A TEST P-CAP INTO THE RETAINER RING, AND IT LOCKED IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED BATTERY TUBE THREADS, CRACKED CASE ON THE BATTERY TUBE SIDE STARTING AT THE LEFT BELT CLIP RAIL, FADED SERIAL NUMBER LABEL. UNIT PASSED DISPLACEMENT, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND SELF TESTS. NO UNEXPECTED ¿REPLACE BATTERY¿, "INSERT BATTERY", OR ¿BATTERY FAILED¿ ERRORS WERE NOTED DURING TESTING. THUS SOFTWARE WAS UTILIZED AND UPLOADED TRACE/HISTORY FILES PROPERLY. NO PUMP ERROR 25 WAS NOTED DURING TESTING, IN THE PUMP HISTORY FILE, IN THE LONG TRACE FILE, OR IN THE POWER MANAGEMENT GRAPH. THE ADAPT TOOL CONFIRMS MULTIPLE OCCURRENCES OF THE FOLLOWING ALERTS/ALARMS AROUND THE EVENT DATE: 58=FAILED BATT TEST @ 09/12/2021 19:04:20.000, 09/12/2021 19:05:03.000, 09/12/2021 19:05:48.000, 09/12/2021 19:06:09.000, 09/12/2021 19:06:54.000, 09/22/2021 06:18:45.000, 09/22/2021 06:19:32.000; 73=CHANGE BATTERY FAULT @ 09/30/2021 10:14:00.000. THE ADAPT TOOL DOES NOT LIST ANY PUMP ERRORS WHICH COULD POTENTIALLY TRIGGER A CRITICAL PUMP ERROR. THE CASE WAS CUT OPEN. AFTER VISUAL INSPECTION, DID NOT NOTE ANY SIGNS OF PREVIOUS MOISTURE PRESENCE OR CORROSION ON ANY OF THE BOARDS, ASSEMBLIES, AND THE MOTOR INSIDE THE UNIT. IN SUMMARY, THE CUSTOMER¿S REPORT OF A CRACK ON THE BATTERY COMPARTMENT WAS CONFIRMED AND THE UNIT REJECTS BATTERIES WAS NOT CONFIRMED. 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DID NOT TAKE ANY BATTERY ANYMORE AND WAS BROKEN AT THE BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485053 PUMP MMT-1782KL 670G MM RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL HG5AKXR 000000763000365905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown