BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS POWER PACK

    MDR report key: 1014070 · Received March 13, 2008

    Report

    Report Number
    2183996-2008-00340
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K022831
    Removal / Correction Number
    Z-1413-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT REPORTED HIS INSULIN INFUSION DEVICE BEGAN ALARMING AND BEEPING AND DISPLAYING '77' AND '3:00' ON ITS DISPLAY SCREEN. HE STATED THE DEVICE'S POWER PACK HAD BEEN IN USE FOR APPROX 3 WEEKS. HE SAID HE IS AWARE OF THE POWER PACK RECALL, BUT IS NOT SURE WHEN HE RECEIVED THESE POWER PACKS. THE PT WAS ADVISED TO DISCARD ALL RECALLED POWER PACKS AND TO USE ONLY CORRECTED ONES. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-TRONPLUS POWER PACK INSULIN INFUSION PUMP BATTERY LZG DISETRONIC MEDICAL SYSTEMS NA 6090253

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN| INSULIN INFUSION PUMP