BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS POWER PACK

    MDR report key: 1062250 · Received June 17, 2008

    Report

    Report Number
    2183996-2008-00880
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 6, 2008
    Report Date
    June 6, 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
    CA, 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 HE WAS ASLEEP WHEN HIS INSULIN INFUSION DEVICE BEGAN TO CONTINUALLY BEEP. HE STATED WHEN HE LOOKED AT IT, HE HAD A "77" DISPLAYED ON HIS INFUSION DEVICE. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS SITE AND REMOVE THE DEVICE BATTERY WHICH HE DISCOVERED HAD AN EXPIRATION DATE OF 2008-05. THE PT WAS ADVISED THIS WAS A RECALLED BATTERY. THE PT STATED THE BATTERY HAD BEEN IN USE FOR AT LEAST 2 WEEKS AND POSSIBLY MORE. HE SAID, HE WAS AWARE OF THE RECALL, BUT DID NOT THINK HE HAD ANYMORE OF THE RECALLED BATTERIES. THE PT INSERTED A CORRECTED BATTERY HE HAD BEEN SENT INTO HIS INFUSION DEVICE, AND THE DEVICE WORKED PROPERLY. 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. 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 06110056

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR INSULIN INFUSION SET| INSULIN| INSULIN INFUSION PUMP