BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1712KL 640G V4.10 BK SF MG

    MDR report key: 11647440 · Received April 12, 2021

    Report

    Report Number
    2032227-2021-134118
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 7, 2021
    Report Date
    July 5, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000155346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PASSED DISPLACEMENT TEST AND SELF-TEST. THE AUDIO TONES/BEEPS/VIBRATE, AUDIO OPTIONS VOLUME 1-5 FUNCTIONED PROPERLY. NO UNEXPECTED PUMP ERROR 63 FOUND DURING TESTING. HOWEVER, PUMP ERROR 63 ALARM (VARIABLE INFO=03) CONFIRMED IN THE DEVICE HISTORY FILE DUE TO BROKEN TRACE AT PIN CRACKED SOLDER JOINT AT PIN ON KEYPAD ASSEMBLY. 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 · 1

    DEVICE PASSED DISPLACEMENT TEST AND SELF-TEST. THE AUDIO TONES/BEEPS/VIBRATE, AUDIO OPTIONS VOLUME 1-5 FUNCTIONED PROPERLY. NO UNEXPECTED PUMP ERROR 63 FOUND DURING TESTING. HOWEVER, PUMP ERROR 63 ALARM CONFIRMED IN THE DEVICE HISTORY FILE DUE TO A HARDWARE ERROR.

    Additional Manufacturer Narrative · 1

    (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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD HARDWARE LOW LEVEL FAILURES ALARM AT THE TIME OF SELF-TEST. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550205 PUMP MMT-1712KL 640G V4.10 BK SF MG PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712KL A000756534 000000763000155346

    Patients

    Seq Age Sex Outcome Treatment
    1