BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMT-712 PARADIGM INSULIN PUMP

    MDR report key: 11554814 · Received March 23, 2021

    Report

    Report Number
    2032227-2021-127333
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    March 18, 2021
    Report Date
    July 4, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    UDI-DI
    000000763000176860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAR 18, 20221 THE CUSTOMER RETURNED PUMP FOR AN ALLEGED MOTOR ERROR ALARM DURING REWIND. DEVICE PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST. DEVICE HISTORY DOWNLOAD USING THDS WAS SUCCESSFUL. HOWEVER, THERE IS NO DATA AVAILABLE ON (MAR 19, 2021) UNABLE TO PERFORM DATA ANALYSIS FOR MOTOR ERROR COMPLAINT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED BELT CLIP SLOT, STAINED END CAP STICKER, STAINED ADDRESS/SERIAL NUMBER LABEL AND CRACKED RESERVOIR TUBE LIP. THE TEST P-CAP/RESERVOIR DOES LOCK INTO PLACE. NO MOISTURE DAMAGE FOUND ON THE ELECTRONICS, MOTOR, BATTERY TUBE AND VIBRATOR ASSEMBLY NOTED. DEVICE PASSED REQUIRE TESTING. NO UNEXPECTED REWIND ANOMALIES NOTED. NO MOTOR ERROR ALARM NOTED. MOTOR PASSED MOTOR TEST. (NOT CONFIRMED). THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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 INSULIN PUMP HAD MOTOR ERROR ALARM DURING REWIND. AND THERE WERE SOME MOTOR ERROR ALARM IN THE ALARM HISTORY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456115 MMT-712 PARADIGM INSULIN PUMP PUMP, INFUSION, INSULIN LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712WWS C0712WWSJ 000000763000176860

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown