BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS POWER PACK

    MDR report key: 1052849 · Received May 27, 2008

    Report

    Report Number
    2183996-2008-00769
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 17, 2008
    Report Date
    May 17, 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 Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED A "777" WAS DISPLAYED ON THE SCREEN OF HER INSULIN INFUSION DEVICE. DURING TROUBLESHOOTING, IT WAS DISCOVERED THE PT WAS USING A RECALLED BATTERY PACK. THE PT WAS ADVISED TO DISCARD ALL RECALLED BATTERY PACKS. 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 PROD WAS REPLACED AND REQUESTED TO 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 NA 06030242

    Patients

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