BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10-PACK RESERVOIR MMT-342 10PK EXTENDED

    MDR report key: 17016558 · Received May 29, 2023

    Report

    Report Number
    2032227-2023-210674
    Event Type
    Malfunction
    Date Received
    May 29, 2023
    Date of Event
    April 30, 2023
    Report Date
    May 29, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EVALUATED 1 OPEN/USED RESERVOIR. A VISUAL INSPECTION TEST WAS PERFORMED APPENDIX D AND FOUND TRANSFER GUARD¿S NEEDLE WAS NOT CENTERED. TRANSFER GUARD NEEDLE WAS FOUND NOT PARALLEL TO TRANSFER GUARDS BODY AXIS. ALSO PERFORMED PRE-FILL RESERVOIR TEST, USING A NEW LAB RESERVOIR AND FOUND TRANSFER GUARD NO LEAKAGE AND NO AIR BUBBLES ANOMALY DURING FILLING; PER DOP114-811DOC. CONCLUSION: TRANSFER GUARD PASSED PER PRE-FILL TEST; NO LEAKAGE AND NO AIR BUBBLES ANOMALY WERE FOUND DURING TEST BUT FAILED PER VISUAL INSPECTION DUE TO FOUND TRANSFER GUARD¿S NEEDLE WAS NOT CENTERED (TRANSFER GUARD NEEDLES WHICH IS ONLY USED TO FILL THE RESERVOIR WITH INSULIN FROM THE BOTTLE AND IS NOT USED AS PART OF ANY DELIVERY OF INSULIN TO THE PATIENT). 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 A LEAK IN THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED AND THE LEAK OCCURRED IN THE O-RINGS, ALSO LEAK WAS PRESENT AT SNAP CAP, SEPTUM, OR O-RINGS AND THE LEAK PAST THE 2ND O-RING. THE CUSTOMER NOT REPORTED TILTING THE PLUNGER DURING THE FILLING PROCESS AND NOR PULLING THE PLUNGER TOO FAR DOWN THE BARREL. NO AIR BUBBLES WAS PRESENT IN THE RESERVOIR. FLUID/ INSULIN WAS NOT VISIBLE ON THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE RESERVOIR. THE RESERVOIR WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618918 10-PACK RESERVOIR MMT-342 10PK EXTENDED PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-342

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female