BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 17028978 · Received May 31, 2023

    Report

    Report Number
    2032227-2023-211409
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    January 23, 2023
    Report Date
    May 31, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT TEST AT .08650 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS. A REVIEW OF THE PUMP HISTORY FILE REVEALS THE FOLLOWING NO DELIVERY (INSULIN FLOW BLOCKED) ALARMS THAT WERE GENERATED FROM 1/19/2023 TO 1/26/2023 (REPORTING DATE): 01/19/2023 12:13:51 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/19/2023 15:59:04 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/19/2023 15:59:50 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/19/2023 16:30:30 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/19/2023 16:31:54 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/19/2023 16:32:48 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/19/2023 18:07:36 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/19/2023 18:08:20 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/22/2023 03:37:02 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BASAL DELIVERY. 01/24/2023 04:29:54 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/25/2023 20:24:01 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 01/25/2023 20:25:01 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING A BOLUS WIZARD DELIVERY. 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), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED SELECT BUTTON KEYPAD OVERLAY, BROKEN BATTERY TUBE THREADS, CRACKED BATTERY COMPARTMENT AT THE CORNER OF THE BELT CLIP RAILS, AND PILLOWING KEYPAD OVERLAY. INSULIN FLOW BLOCKED ALARMS (INSULIN DELIVERY ENDING EARLY), HIGH BG ANOMALY, AND LOW BG ANOMALY ARE NOT CONFIRMED. THE PUMP PASSED ALL FUNCTIONAL 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RETAINER RING WAS FAILED, AND INSULIN DELIVERY WAS ENDING EARLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT AHS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130856 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL NG3252281H 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male