BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMT-712 PARADIGM INSULIN PUMP

    MDR report key: 12493237 · Received September 18, 2021

    Report

    Report Number
    2032227-2021-194860
    Event Type
    Malfunction
    Date Received
    September 18, 2021
    Date of Event
    September 13, 2021
    Report Date
    February 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    UDI-DI
    000000613994470904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 CUSTOMER RETURNED PUMP FOR AN ALLEGED AA33 ALARM AND E17 ALARM. DRIVE SUPPORT DISK WAS INSPECTED, AND NO ANOMALY WAS NOTED. UNIT RECEIVED A33 ALARM DURING BASIC OCCLUSION TEST DUE TO FAULTY FSR (GOLD). UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST DUE TO A33 ALARM. HOWEVER, UNIT PASSED REWIND TEST AND DISPLACEMENT TEST. ALSO, FAILING DURING A21 ERROR TEST AND RESETS TIME/DATE TO FACTORY DEFAULT AFTER BATTERY CHANGE. NO UNEXPECTED A17 ALARM NOTED DURING TESTING. PUMP HISTORY DOWNLOAD USING THDS WAS SUCCESSFUL. HOWEVER, THERE IS NO DATA AVAILABLE ON (B)(6) 2021), UNABLE TO PERFORM DATA ANALYSIS FOR E/A17 ALARM COMPLAINT. SWAPPING OUT TEST INTERFACE BOARDS CONFIRMS A21 ALARMED AND MEASURE C13 VOLTAGE LEAK AT INTERFACE BOARD. PUMP WAS CUT AND OPEN MOISTURE DAMAGE FOUND ON THE MOTOR AND VIBRATOR ASSEMBLY NOTED. THE TEST RESERVOIR LOCKED IN PLACE PROPERLY AND NO ANOMALY NOTED. UNIT HAD SCRATCHED CASE. UNIT RECEIVED WITH AA33 ALARM DURING THE BASIC OCCLUSION TEST DUE TO FAULTY FSR (GOLD) AND PUMP FAILED A21 TEST DUE TO C13 VOLTAGE LEAK AT INTERFACE BOARD WAS CONFIRMED. NO UNEXPECTED A17 ALARM NOTED DURING TESTING. 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 HAD MULTIPLE PUMP ERROR ALARMS. 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
    1390597 MMT-712 PARADIGM INSULIN PUMP PUMP, INFUSION, INSULIN LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712WWS B1712WWSJ1 000000613994470904

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown