BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 17796872 · Received September 22, 2023

    Report

    Report Number
    2032227-2023-275053
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 2, 2023
    Report Date
    November 15, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, AND DISPLACEMENT TEST. THE PUMP HISTORY AND TRACE FILES WERE SUCCESSFULLY DOWNLOADED USING THUMP. THERE WERE NO PUMP ERROR 43 ALARMS DURING TESTING. A REVIEW OF THE PUMP HISTORY FILE SHOWS ON 9/2/2023 THERE WERE THREE (3) PUMP ERROR 43 ALARMS (15:24:08, 15:25:56, AND 15:26:39) AND TWO (2) PUMP ERROR 130 ALARMS (15:21:12 AND 15:24:12), LISTED BELOW: 09/02/2023 15:21:12 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MFDAALARM (130) LINENUMBER: 613 FILENUMBER: 121. 09/02/2023 15:24:08 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 763 FILENUMBER: 121. 09/02/2023 15:24:12 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MFDAALARM (130) LINENUMBER: 613 FILENUMBER: 121. 09/02/2023 15:25:56 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 763 FILENUMBER: 121. 09/02/2023 15:26:39 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 763 FILENUMBER: 121. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, AND MOTOR FLEX TAIL. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, SERIAL NUMBER LABEL FADING, PILLOWING KEYPAD OVERLAY, CRACKED BATTERY COMPARTMENT AT THE CORNER OF THE BELT CLIP RAILS, AND CRACKED BATTERY TUBE THREADS. PUMP ERROR 43 AND PUMP ERROR 130 ALARMS ARE CONFIRMED DUE TO MOISTURE DAMAGE ON THE HARDWARE. COSMETIC DAMAGE ON THE BATTERY COMPARTMENT AND BATTERY TUBE THREADS IS CONFIRMED. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 A "AN ERROR IN THE MOTOR WAS DETECTED BY READING UNEXPECTED VALUE FROM HALL SENSOR" (PUMP ERROR 43). TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS UNABLE TO CLEAR THE ALARM, ABLE TO COMPLETE THE REWIND AND ALSO THERE'S A CRACK ON BATTERY COMPARTMENT, BACK OF THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND IT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83883 PUMP MMT-1884L MM780G BLE 3.0 MG/ML AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884L NG3305360H

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male