BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 13041471 · Received December 20, 2021

    Report

    Report Number
    2032227-2021-232219
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    December 14, 2021
    Report Date
    June 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. PUMP WAS RETURNED FOR A PUMP ERROR 63, PUMP ERROR 54 AND 3 ALARMS ON 24-JAN-2022. PUMP'S HISTORY AND TRACE FILES DOWNLOADED SUCCESSFULLY USING THUS SOFTWARE. PUMP PASSED DISPLACEMENT TEST, BUT FAILED SELF TEST. PUMP ERROR 63 ALARM PRESENT DURING TESTING. PUMP ERROR 63 WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF 12/14/2021 AT 3:20PM (VARIABLE INFO = 3). PUMP ERROR 54 WAS PRESENT IN PUMP HISTORY ON 12/14/2021 AT 3:35PM. ESF #: (B)(4). LINE NUMBER = 1421. FILE NUMBER = 32122. PUMP ERROR 3 WAS PRESENT IN HISTORY DOWNLOAD ON 12/14/2021 AT 3:25PM PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. TEST P - CAP/ RESERVOIR LOCKS PROPERLY INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED CASE, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, BATTERY TUBE THREADS - CRACKED AND CORRODED BATTERY TUBE. PUMP ERROR 63 WAS CONFIRMED IN THE FORMATTED HISTORY FILE (VARIABLE INFO = 3) DUE TO BROKEN TRACE AT PIN #6 SDA AND #1 VDD AT U1 KEYPAD ASSEMBLY. PUMP ERROR 54 WAS CONFIRMED IN THE FORMATTED HISTORY FILE ON 12/14/2021 AT 3:35PM. DUE TO A SOFTWARE ANOMALY. ESF #: (B)(4). LINE NUMBER = 1421. FILE NUMBER = 32122. PUMP ERROR 3 WAS A CONSEQUENCE OF PUMP ERROR 54. 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

    (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 · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. TROUBLESHOOTING WAS DONE AND CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. CUSTOMER WAS PERFORMED SELF TEST WAS AND IT WAS FAILED. 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
    1939577 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG3WFK7 000000763000283544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown