BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 5734154 · Received June 17, 2016

    Report

    Report Number
    2032227-2016-12256
    Event Type
    Malfunction
    Date Received
    June 17, 2016
    Date of Event
    July 28, 2015
    Report Date
    August 12, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH FSD DUE TO A BROKEN SOLDER JOINT PIN # 1, 7 OF FLEX KEYPAD CONNECTOR CONTACT. UNABLE TO PERFORM FUNCTIONAL TESTINGS DUE TO FSD. THE UNIT HAD A CRACKED OVERLAY AND A MINOR SCRATCHED OVERLAY.

    Description of Event or Problem · 1

    THE PRODUCT WAS RETURNED TO MEDTRONIC AND NO COMPLAINT WAS MADE. THE CUSTOMER'S BLOOD GLUCOSE READING WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386777 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR