BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 12931971 · Received December 6, 2021

    Report

    Report Number
    2032227-2021-226699
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 25, 2021
    Report Date
    June 29, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. THE CUSTOMER RETURNED THE INSULIN PUMP FOR ALLEGED VOLUME SETTING ADJUSTED AND NO CHANGE IN THE SOUND WHILE ADJUSTING THE SETTINGS AND NO SOUND DURING ALERTS (B)(6) 2021. DEVICE PASSED THE DISPLACEMENT TEST AND SELF TEST. ADJUSTED THE AUDIO OPTIONS AUDIO VOLUME 1-5 AND EACH SETTING FUNCTIONED PROPERLY. REMOVED THE BATTERY CAP AND THE PUMP ALARMED INSERT BATTERY WITH AUDIO TONES PROPERLY. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. A REVIEW OF THE DOWNLOADED HISTORY FILES SHOW THERE ARE NO PUMP ERROR 63 ALARMS. DEVICE WAS PROGRAMMED WITH A GUARDIAN LINK 3 TRANSMITTER AND TEST PLUG. DEVICE CALIBRATED TO THE PROGRAMMED TEST VALUES PROPERLY AND DISPLAYED CORRECTLY ON THE DISPLAY GRAPH. PROGRAMMED THE ALERT ON HIGH ALARM TO 12.0 MMOL/L, CALIBRATED THE PUMP FOR A 13.3 MMOL/L, AND AFTER THE CALIBRATION THE PUMP ALARMED ALERT ON HIGH AT 13.3 MMOL/L PROPERLY. DEVICE WAS MONITORED FOR SEVERAL DAYS WITH NO ERRORS OR ALARMS. NO ABSENCE OF AUDIO TONES ANOMALY NOTED DURING TESTING. DEVICE WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO DAMAGE OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING PHYSICAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY. NO AUDIO ANOMALY IS NOT CONFIRMED. DEVICE ALARMED (VIBRATE AND AUDIO TONES) PROPERLY DURING TESTING. 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 · 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 AUDIO ANOMALY. CUSTOMER STATED THAT PUMP WAS NOT ALARMING WITH SOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829891 PUMP MMT-1782KL 670G MM RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL HG5CC8N 000000763000365905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown