BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS POWER PACK

    MDR report key: 1193224 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01486
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    Z-1413-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT HIS INFUSION DEVICE WAS GIVING A BUZZING NOISE AND "3.0" AND "77" WERE DISPLAYED ON THE SCREEN AND THE SCREEN WAS FROZEN. THE PATIENT WAS INSTRUCTED TO REMOVE THE POWER PACK, AND HE STATED THE EXPIRATION DATE WAS 2006-03. THE PATIENT WAS INSTRUCTED TO INSERT A NEW POWER PACK AND THE INFUSION DEVICE FUNCTIONED PROPERLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT WAS ADVISED OF THE RECALL AND INSTRUCTED TO DISCARD ALL RECALLED OR EXPIRED POWER PACKS. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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 06090117

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR INSULIN INFUSION SET| INSULIN INFUSION PUMP| INSULIN