BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 13692168 · Received March 8, 2022

    Report

    Report Number
    2032227-2022-121715
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    March 2, 2022
    Report Date
    June 29, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST AND SELF TEST. ADJUSTED THE AUDIO OPTIONS AUDIO VOLUME 1-5 AND EACH SETTING FUNCTIONED PROPERLY (NO LOUDER THAN NORMAL AUDIO TONES). SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. NO PUMP ERROR 63 ALARMS ARE FOUND IN THE DOWNLOADED HISTORY FILES. NO LOUDER THAN NORMAL AUDIO TONES OR SAME AUDIO WHEN SWITCHING THE VOLUME ANOMALY NOTED DURING TESTING. THE PUMP WAS CUT OPEN FOR VISUAL INSPECTION. NO DAMAGE OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), THE MOTOR, OR THE FORCE SENSOR NOTED. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING PHYSICAL INSPECTION: SCRATCHED CASE, MISSING DISPLAY WINDOW COVER, SERIAL NUMBER LABEL PEELING, AND PILLOWING KEYPAD OVERLAY. LOUDER THAN NORMAL AUDIO TONES OR SAME AUDIO WHEN SWITCHING THE VOLUME ARE NOT 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AUDIO ANOMALY. CUSTOMER STATED THAT THERE WAS LOUD BEEP VIBRATE AUDIO. NEW BATTERY DID NOT RESTORE NORMAL INSULIN PUMP FUNCTION. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097125 PUMP MMT-1880L MM770G BLE MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L HG53TU3 000000763000439866

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male