BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751LNAS

    MDR report key: 8682377 · Received June 10, 2019

    Report

    Report Number
    2032227-2019-13971
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    June 2, 2019
    Report Date
    July 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE ALARMED A35 DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST OR VERIFY MOTOR ERROR, LOW RESERVOIR, BATTERY OUT LIMIT ALARMS DUE TO A35 ALARM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR AND MOTION SENSOR TEST FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ABLE TO CLEAR THE ALARMS. CUSTOMER WAS NOT ABLE TO COMPLETE INSULIN PUMP REWIND.. THE CUSTOMER ALSO REPORTED THAT THE DISPLACEMENT VERIFICATION TEST AND THE INSULIN PUMP RECEIVED AN ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477702 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751LNAS A6751LNASJ 00763000161170

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR