BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 8622265 · Received May 18, 2019

    Report

    Report Number
    3004209178-2019-99006
    Event Type
    Malfunction
    Date Received
    May 18, 2019
    Date of Event
    May 15, 2019
    Report Date
    July 24, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH CRITICAL PUMP ERROR (OPEN BOOK) AFTER BATTERY INSTALLATION AND UNABLE TO DOWNLOAD, PROBLEM ISOLATED TO ELECTRONIC ASSEMBLY. UNABLE TO PERFORM FUNCTIONAL TEST INCLUDING SELF TEST, REWIND, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR.FORCE SENSOR ZERO OFFSET MEASURED WITHIN SPEC RANGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR AND PUMP ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 167 MG/DL. THE CUSTOMER REPORTED THAT THEY RECEIVED A CRITICAL PUMP ERROR IMAGE ON THE PUMP SCREEN. IT WAS REPORTED THAT THEY HAD PUMP ERROR WAS DISPLAYED BEFORE THE OPEN BOOK IMAGE WAS DISPLAYED ON THE SCREEN. CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415571 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG2FAWT 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR