BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS POWER PACK

    MDR report key: 1163441 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01380
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HIS INSULIN INFUSION DEVICE DISPLAYED "77." HE STATED THIS MESSAGE WOULD NOT CLEAR. THE TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO REMOVE THE BATTERIES. THE PATIENT STATED HE WAS CURRENTLY DRIVING, BUT WOULD REMOVE AND CHANGE THE BATTERIES WHEN HE ARRIVED HOME. THE PT WAS CONTACTED LATER THE SAME DAY, AND IT WAS DETERMINED THAT THE BATTERIES AT ISSUE WERE PART OF THE RECALL. THE PT WAS ADVISED TO DISCARD ALL RECALLED BATTERIES. THE PT WAS IN THE PROCESS OF SWITCHING TO A NEW INSULIN INFUSION DEVICE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR INSULIN| INSULIN INFUSION PUMP| INSULIN INFUSION SET