BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 18090581 · Received November 8, 2023

    Report

    Report Number
    2032227-2023-299483
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 4, 2023
    Report Date
    November 8, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    UDI-DI
    002076300027335801
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. CUSTOMER CONCERN: PT SAID THAT SHE CANNOT PUSH THE INSULIN FROM THE RESERVOIR TO HER TUBING. EVALUATED 2 OPEN/USED RESERVOIRS (NO CLEAR LIQUID INSIDE). A VISUAL INSPECTION WAS PERFORMED USING APPENDIX D; CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WAS FOUND. PERFORMED PRE-FILL TEST APPENDIX C. FOUND TRANSFER GUARDS NO OCCLUDED DURING ANALYSIS. PER DOP114-811DOC. CONCLUSION: BOTH RESERVOIRS AND TRANSFER GUARDS PASSED PER PRE-FILL TEST, NO OCCLUDED ANOMALY DURING TEST. EVALUATED 1 RANDOM SEAL RESERVOIR AND TRANSFER GUARD. A VISUAL INSPECTION WAS PERFORMED USING APPENDIX D; CHECKED O-RINGS AND STOPPER GROOVE FOR DEFECTS AND NONE WAS FOUND. PERFORMED PRE-FILL TEST APPENDIX C. FOUND NO OCCLUDED DURING ANALYSIS. PER DOP114-811DOC. CONCLUSION: RESERVOIR AND TRANSFER GUARD PASSED PER PRE-FILL TEST; NO OCCLUDED ANOMALY WAS FOUND DURING TEST. 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 THAT THE INSULIN FROM THE RESERVOIR TO HER TUBING. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE AND THE RESERVOIR WILL BE RETURNED FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277627 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG6Q94R 002076300027335801

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female