BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 18036517 · Received October 31, 2023

    Report

    Report Number
    2032227-2023-293626
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    August 12, 2023
    Report Date
    October 30, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000264727
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    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. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. AFTER MULTIPLE BATTERY REPLACEMENT UNIT PERSISTED ON BLANK DISPLAY. PUMP RECEIVED WITH BLANK DISPLAY DUE TO CRACKED CASE BEHIND THE PUMP AT THE BATTERY COMPARTMENT CAUSING THE BATTERY TUBE TO BECOME LOOSE AND TEST BATTERY CAP NOT MAKING CONTACT TO THE BATTERY TUBE. CUT UNIT OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC ASSEMBLY. AFTER POSITIONING THE ELECTRONIC ASSEMBLY INTO A NEW CASE UNIT REMAINED BLANK DISPLAY. PER VISUAL INSPECTION, CORRODED ELECTRONIC ASSEMBLY AND CORRODED VIBRATOR HARNESS/POWER BOARD NOTED. UNIT ALSO RECEIVED WITH CRACKED CASE (BATTERY TUBE), CRACKED BATTERY TUBE THREADS, MISSING SERIAL NUMBER LABEL, DAMAGE DISPLAY WINDOW COVER AND SCRATCHED CASE. IN CONCLUSION, UNIT WAS RECEIVED WITH A BLANK DISPLAY DUE TO CRACKED CASE IN MULTIPLE LOCATIONS CAUSING THE BATTERY TUBE TO BECOME LOOSE AND TEST BATTERY CAP NOT MAKING CONTACT TO THE BATTERY TUBE. AFTER POSITIONING THE ELECTRONIC ASSEMBLY INTO A NEW CASE UNIT REMAINED BLANK DUE TO CORRODED ELECTRONIC ASSEMBLY. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED DAMAGE NEAR BATTERY COMPARTMENT. TROUBLESHOOTING WAS PERFORMED AND NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. ADVISED CUSTOMER TO DISCONTINUE PUMP AND REVERT BACK TO HCP¿S INSTRUCTIONS . THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070382 PUMP MMT-1782K 670G V4.11 MM AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K 000000763000264727

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Unknown