BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 13974020 · Received April 1, 2022

    Report

    Report Number
    2032227-2022-174746
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 29, 2022
    Report Date
    July 18, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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

    RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED BLANK DISPLAY, COSMETIC DAMAGE LOCATED AT THE BATTERY TUBE, POSSIBLE MOISTURE DAMAGE FOUND ON 29-MAR-2022. PUMP RECEIVED WITH BLANK DISPLAY. UNABLE TO PERFORM THE DISPLACEMENT TEST, SLEEP CURRENT TEST, ACTIVE CURRENT TEST AND SELF TEST DUE TO BLANK DISPLAY. UNABLE TO DOWNLOAD THE PUMP HISTORY AND TRACES USING THE THUMP SOFTWARE DUE TO BLANK DISPLAY. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR, HOME SWITCH AND HARNESS ASSEMBLY VIBRATOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED CASE, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, SERIAL NUMBER LABEL PEELING, MOISTURE DAMAGE. IN SUMMARY, CUSTOMER¿S ALLEGED BLANK DISPLAY WAS CONFIRMED DUE TO SEVERE CORROSION ON THE J7 CONNECTOR¿S SOLDER JOINTS ON PCBA 1 AND ON THE J1 CONNECTOR'S SOLDER JOINTS ON PCBA 2. ADDITIONALLY, CUSTOMER¿S ALLEGED COSMETIC DAMAGE LOCATED AT THE BATTERY TUBE WAS CONFIRMED BY VISUAL INSPECTION WHERE A CRACKED BATTERY TUBE WAS NOTED. UNABLE TO DOWNLOAD CONFIRMED DUE TO BLANK DISPLAY. 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 A BLANK SCREEN. CUSTOMER STATED THE INSULIN PUMP WAS BROKEN AND GOT WET. CUSTOMER STATED DISPLAY WAS BLANK CURRENTLY. 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
    1704212 PUMP MMT-1880L MM770G BLE MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L HG5J4HQ 000000763000439866

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female