BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751LNAS

    MDR report key: 9731548 · Received February 20, 2020

    Report

    Report Number
    3004209178-2020-72818
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    February 16, 2020
    Report Date
    April 16, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING NOTED. UNABLE TO PERFORM ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, OPERATING CURRENTS, A21 ERROR TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME A33 AND EXCESSIVE NO DELIVERY TEST DUE TO BUTTONS NOT RESPONDING.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER STATED THAT ACT BUTTON WAS NOT EXECUTING. CUSTOMER WAS TRIED TO DELIVER BOLUS AND UNABLE TO ACCESS THE MENU AS THE ACT BUTTON WAS NOT WORKING AFTER PRESSING MULTIPLE TIMES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196346 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 65 YR