BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10-PACK RESERVOIR MMT-342 10PK EXTENDED

    MDR report key: 17132936 · Received June 15, 2023

    Report

    Report Number
    2032227-2023-218218
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 18, 2023
    Report Date
    July 31, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    UDI-DI
    002076300049718101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CONCERN: PRESSURE DURING FILLING UP THE RESERVOIR AND WALK THROUGH WITH THE DIABETES EDUCATOR ON HOW TO FILL THE RESERVOIR AND WAS TOLD TO CALL BECAUSE SHE MAY HAD A BAD BATCH OF RESERVOIR. EVALUATED 4 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 (B)(4). CONCLUSION: ALL 4 RESERVOIRS AND TRANSFER GUARDS PASSED PER PRE-FILL TEST, NO OCCLUDED ANOMALY DURING TEST. EVALUATED 2 OPEN/USED RESERVOIRS ONLY; TRANSFER GUARDS NOT RETURNED (NO CLEAR LIQUID INSIDE)) PERFORMED PRE-FILL RESERVOIR TEST. USING A NEW LAB TRANSFER GUARD; AND FOUND RESERVOIRS NO OCCLUDED ANOMALY DURING FILLING; PER (B)(4). CONCLUSION: RESERVOIRS PASSED PER INSPECTION NO OCCLUDED ANOMALY WAS FOUND DURING TEST, WHEN USING A NEW LAB TRANSFER GUARD. 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 · 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. 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. 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 RECEIVED AN INSULIN FLOW BLOCK PRESSURE DURING FILLING UP THE RESERVOIR. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND THE CUSTOMER REPORTED ISSUE WITH THE RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE RESERVOIR. ONE OF THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956931 10-PACK RESERVOIR MMT-342 10PK EXTENDED PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-342 HG6V333 002076300049718101

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female