BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 13909119 · Received March 25, 2022

    Report

    Report Number
    2032227-2022-142178
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Date of Event
    August 29, 2021
    Report Date
    May 19, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169782396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. (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.

    Additional Manufacturer Narrative · 0

    RETAINER RING=CLEAR. CUSTOMER COMPLAINED ON 08/31/2021 THE PUMP ALARMED PUMP ERROR 2, PUMP ERROR 28, PUMP ERROR 63 AND PUMP ERROR 79. COMPLAINED IS EXPERIENCING HIGH BG. UNIT PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. NO PUMP ERROR 2, PUMP ERROR 28, PUMP ERROR 63 OR PUMP ERROR 79 NOTED DURING TEST. HOWEVER, CONFIRMED THE PUMP ALARMED PUMP ERROR 2 ON 08/29/2021 10:22:26.000, PUMP ERROR 28 ON 08/29/2021 10:21:16.000, PUMP ERROR 63 VARIABLE 9 ON 08/29/2021 10:22:04.000 AND PUMP ERROR 79 ON 08/29/2021 10:21:00.000 DUE TO MOISTURE DAMAGED TO THE PCB1 AND PCB2 BOARD. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, PCB1 BOARD AND PCB 2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED BATTERY TUBE, CORRODED MOTOR HOME SWITCH, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE) AND CRACKED RETAINER. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. PUMP PASSED FUNCTIONAL TESTING. NO PUMP ERROR 2, PUMP ERROR 28, PUMP ERROR 63 OR PUMP ERROR 79 NOTED DURING TEST. HOWEVER, CONFIRMED THE PUMP ALARMED PUMP ERROR 2 ON 08/29/2021 10:22:26.000, PUMP ERROR 28 ON 08/29/2021 10:21:16.000, PUMP ERROR 63 VARIABLE 9 ON 08/29/2021 10:22:04.000 AND PUMP ERROR 79 ON 08/29/2021 10:21:00.000 DUE TO MOISTURE DAMAGED TO THE PCB1 AND PCB2 BOARD. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PUMP ERROR 63, PUMP ERROR 2, PUMP ERROR 79, PUMP ERROR 28 OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053878 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG32X2N 000000643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown