BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-TRONPLUS POWER PACK

    MDR report key: 1003865 · Received April 13, 2007

    Report

    Report Number
    2183996-2007-00515
    Event Type
    Injury
    Date Received
    April 13, 2007
    Date of Event
    March 30, 2007
    Report Date
    March 30, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K022831
    Removal / Correction Number
    Z-1413-6
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT STATED THAT HER INFUSION DEVICE WAS IN THE STOP MODE AND SHE WAS NOT ABLE TO PLACE IT BACK INTO RUN. SHE STATED THAT SHE INSERTED A NEW POWER PACK INTO THE DEVICE, AND SHE SAW THE STOP SIGN ON THE DISPLAY OF THE INFUSION DEVICE ALONG WITH "S" FLASHING. SHE STATED THAT SHE WAS NOT ABLE TO ADVANCE THE MENU OF THE DEVICE. THE PT WAS INSTRUCTED TO INSERT ANOTHER NEW POWER PACK. THE INFUSION DEVICE AGAIN DISPLAYED STOP WITH A FLASHING "S" AND SHE WAS NOT ABLE TO ADVANCE THE MENU. THE PT STATED THAT SHE ALSO HAD ELEVATED BLOOD GLUCOSE OF 600 MG/DL. SHE STATED THAT A NORMAL BLOOD GLUCOSE READING FOR HER IS AROUND 200 MG/DL. SHE STATED THAT SHE FELT REALLY SICK AND GAVE HERSELF INSULIN INJECTIONS AND BOLUSED TO LOWER HER BLOOD GLUCOSE. THE PT'S PHYSICIAN ADVISED HER TO INCREASE HER HOURLY BASAL RATE FROM 1.2 UNITS PER HOUR TO 2.0 UNITS PER HOUR. THE PT WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE. ATTEMPTS TO CONTACT THE PT FOR FOLLOW UP WERE UNSUCCESSFUL. PRODUCT WAS 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, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R INSULIN| INSULIN INFUSION SET| INSULIN INFUSION PUMP