BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 11573006 · Received March 25, 2021

    Report

    Report Number
    2032227-2021-128333
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    March 19, 2021
    Report Date
    May 27, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000166519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. NO FAILED BATTERY TEST ALERTS NOTED WHEN INSERTING A NEW BATTERY OR DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED CASE NEAR THE CORNER OF BELT CLIP RAILS, CRACKED KEYPAD OVERLAY, AND CRACKED CASE ON THE BATTERY TUBE SIDE. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR BLOOD GLUCOSE LEVEL RANGES FROM 49 MG/DL TO 459 MG/DL. CUSTOMER STATED THAT THEIR LOW BLOOD GLUCOSE LEVEL SNEAK UP AND THEY HAD THEIR LOWS IN EARLY AFTERNOON. CUSTOMER STATED THAT INSULIN PUMP REJECTS NEW BATTERIES. CUSTOMER STATED THAT INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARM. CUSTOMER STATED THAT INSULIN PUMP LOST SETTINGS PREVIOUSLY AND THEY HAD TO GO IN AND RESET IT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469686 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG3BFRJ 000000763000166519

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other FRN-MMT-332-RSVR, UNOMED INF SET| FRN-MMT-332-RSVR, UNOMED INF SET