BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS POWER PACK

    MDR report key: 3112177 · Received July 16, 2007

    Report

    Report Number
    2183996-2007-00343
    Event Type
    Malfunction
    Date Received
    July 16, 2007
    Date of Event
    March 11, 2007
    Report Date
    March 12, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT STATED THAT ON (B)(6) 2007 SHE WAS RETRACTING HER PISTON ROD TO CHANGE THE INSULIN CARTRIDGE AND HER INFUSION DEVICE BEGAN MAKING A "SQUEALING NOISE." SHE STATED SHE REMOVED AND REINSERTED THE POWER PACK AND THE DEVICE MADE THE SAME NOISE. SHE WAS INSTRUCTED TO INSERT A NEW POWER PACK AND THE DEVICE MADE THE SAME NOISE. SHE WAS INSTRUCTED TO INSERT A NEW POWER PACK AND THE DEVICE FUNCTIONED PROPERLY. SHE STATED THAT HER POWER PACK WAS 10 DAYS OLD. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS DISCARDED, THEREFORE, NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN INFUSION SET| INSULIN INFUSION PUMP| INSULIN