BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 16352473 · Received February 10, 2023

    Report

    Report Number
    2032227-2023-155100
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 26, 2023
    Report Date
    March 17, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000586195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE PUMP FOR ALLEGED MULTIPLE PUMP ERROR 43 ALARMS DURING REWIND AND THE TIME CLOCK IS NOT ADVANCING FOUND ON (B)(6) 2023. THE PUMP SEATS IMMEDIATELY DURING THE PRIME/FILL PROCESS AND WILL NOT REWIND. THE PUMP PASSED THE SELF TEST HOWEVER, UNABLE TO PERFORM THE REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, AND DISPLACEMENT TEST, OR VERIFY PUMP ERROR 43 ALARMS (DRIVE/MOTOR TESTS) DUE TO PRIME/FILL AND REWIND ANOMALIES. THE PUMP HISTORY AND TRACE FILES WERE SUCCESSFULLY DOWNLOADED USING THUS. PROGRAMMED THE PUMP WITH THE CURRENT TIME AND DATE AND WAS MONITORED FOR 48 HOURS. THE TIME AND DATE DISPLAYED AND FUNCTIONED PROPERLY. A REVIEW OF THE PUMP HISTORY FILE REVEALS ON (B)(6) 2023 THERE WERE EIGHT (8) PUMP ERROR 43 ALARMS THAT OCCURRED, LISTED BELOW: (B)(6) 2023 17:52:30 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 752 FILENUMBER: 121; (B)(6) 2023 17:56:25 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 752 FILENUMBER: 121; (B)(6) 2023 17:57:00 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 752 FILENUMBER: 121; (B)(6) 2023 18:01:55 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 752 FILENUMBER: 121; (B)(6) 2023 18:03:24 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 752 FILENUMBER: 121 (B)(6) 2023 18:06:17 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 752 FILENUMBER: 121; (B)(6) 2023 18:11:24 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 752 FILENUMBER: 121; (B)(6) 2023 18:13:54 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORDRIVEERROR (43) LINENUMBER: 752 FILENUMBER: 121. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2) AND FORCE SENSOR HOWEVER, FOUND THE MOTOR GEARBOX WAS JAMMED. PUMP ERROR 43 ALARMS THAT ARE LOCATED IN THE PUMP HISTORY FILE, PRIME/FILL ANOMALY, AND REWIND ANOMALY ARE DUE TO A JAMMED MOTOR GEARBOX. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. PUMP ERROR 43 ALARM, PRIME/FILL ANOMALY, AND REWIND ANOMALY ARE CONFIRMED DUE TO A JAMMED MOTOR GEARBOX. NO UNEXPECTED TIME ANOMALY WAS NOTED DURING TESTING. 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. 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 CUSTOMER REPORTED PUMP ERROR 43. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE PUMP AND THE PUMP WILL  BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49683 PUMP MMT-1880L MM770G BLE MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L HG6E4JB 000000763000586195

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male