BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4140820 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32752
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THE PUMP WAS RECEIVED WITH MISSING SEGMENTS DUE TO OPEN HEAT BOND OF ZEBRA CONNECTOR ON SHORT SIDE ON THE LCD. THE PUMP ALSO HAD A CRACKED OVERLAY, MINOR SCRATCHED OVERLAY, A CRACKED CASE UNDER OVERLAY AND DEBRIS UNDER OVERLAY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP'S DISPLAY WAS VERY DIFFICULT TO READ. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620219 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508LGB

    Patients

    Seq Age Sex Outcome Treatment
    1