BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 8797449 · Received July 17, 2019

    Report

    Report Number
    2032227-2019-31136
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 6, 2019
    Report Date
    June 2, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169782396
    Removal / Correction Number
    Z-0955-2020
    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. UPDATED H9: Z-0955-2020. 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

    INSULIN PUMP PASSED SELF TEST. NO UNEXPECTED PUMP ERROR 15 ALARMS DURING TESTING HOWEVER, PUMP ERROR 15 ALARM, LINE NUMBER 213 FILE NUMBER 30, IS FOUND IN THE FORMATTED HISTORY FILE DUE TO A SOFTWARE ERROR. INSULIN PUMP WAS RECEIVED WITH PARTIALLY BROKEN RESERVOIR TUBE LIP, MISSING RESERVOIR TUBE O-RING AND MISSING RESERVOIR RETAINER. UNABLE TO PERFORM DISPLACEMENT TEST AND RESERVOIR UNABLE TO LOCK INTO PLACE DUE TO PARTIALLY BROKEN RESERVOIR TUBE LIP, MISSING RESERVOIR TUBE O-RING AND MISSING RESERVOIR RETAINER.

    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

    IT WAS REPORTED THAT THE LIP OF RESERVOIR WAS CRACK AND RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE WAS 12 MMOL/L AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP AND ALSO STATED THAT THEY PERFORMED THE SELF TEST ABLE TO PASSE THE REST. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593598 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG2NK8V 00643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown