BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12171581 · Received July 15, 2021

    Report

    Report Number
    2032227-2021-167713
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    July 7, 2021
    Report Date
    October 19, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. DEVICE PASSED DISPLACEMENT TEST, SELF TEST, SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WITHIN SPECIFICATIONS. DEVICE WAS MONITORED AND FUNCTIONING PROPERLY. NO UNEXPECTED BLANK DISPLAY NOTED DURING TESTING. DEVICE WAS CUT/OPEN AND INSPECTED NO MOISTURE DAMAGE OR COMPONENT DAMAGE FOUND INSIDE THE INSULIN PUMP. DEVICE HISTORY WAS DOWNLOAD SUCCESSFULLY AND POWER MANAGEMENT GRAPH SUCCESSFULLY GENERATED. NO UNEXPECTED POWER ALARMS OR POWER ANOMALIES DURING THE TESTING. HOWEVER, BATTERY OUT LIMIT WAS FOUND AND RECORDED AT FORMATTED HISTORY FILE ON (B)(6) 2021 00:06:37.000 ALARM ALERT NOTIFICATION FAULT NUMBER = BATTERY OUT LIMIT(6). DEVICE RECEIVED WITH CRACKED SELECT BUTTON KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT. TEST RESERVOIR/PCAP LOCK PROPERLY INSIDE THE RESERVOIR TUBE. DEVICE BATTERY CAP FUNCTIONING PROPERLY NOTED. 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 · 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP NO MORE TURNING ON. THE CUSTOMER STATED THAT THEY NOTICED A CRACK ON THE BACK OF THE INSULIN PUMP. CUSTOMER STATED THAT BECAUSE OF PUTTING THE BATTERY CAP ON THE INSULIN PUMP IT CRACKED. CUSTOMER STATED THAT NO DAMAGE TO PUMPS RETAINER RING OCCURRED. 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
    1075219 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG3W00L 000000763000283506

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR