BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 7318268 · Received March 6, 2018

    Report

    Report Number
    3004209178-2018-54894
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    February 17, 2018
    Report Date
    September 27, 2018
    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
    PATIENT

    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

    NO UNEXPECTED INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR ALARM OR THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM ALARMS DURING TESTING HOWEVER, INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR ALARM AND THE MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM ALARM ARE FOUND IN THE FORMATTED HISTORY FILE DUE TO A SOFTWARE ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ARM CANNOT COMMUNICATE WITH THE MAIN ARM ERROR AND THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO ERROR ALARMS DURING BOLUS. CUSTOMER BLOOD GLUCOSE LEVEL WAS 233 MG/DL. THE CUSTOMER WILL RETURN INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159059 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG280CN 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR