BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS POWER PACK

    MDR report key: 1082207 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01100
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED, SHE RECEIVED AN 03 (LOW ELECTRONIC BATTERY) MESSAGE ON HER INSULIN INFUSION DEVICE BEFORE SHE WENT TO BED. SHE STATED SHE CHANGED HER BATTERY BUT DID NOT CHECK THE EXPIRATION AND WENT TO BED. SHE SAID, SHE WOKE UP THIS MORNING WITH A BLOOD GLUCOSE READING OF 600 MG/DL WITH HER NORMAL RANGE BEING 150-160 MG/DL. SYMPTOMS ARE NAUSEA AND NOT FEELING WELL AND SHE GAVE HERSELF AN INJECTION OF INSULIN. THE PATIENT STATED WHEN SHE TRIED TO BOLUS, SHE NOTICED THE DEVICE DISPLAY SCREEN WAS BLANK AND THE DEVICE WAS MAKING A BUZZING NOISE. TO TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO REMOVE THE BATTERIES AND CHECK THE EXPIRATION DATE. THE PATIENT DISCOVERED THE BATTERIES EXPIRED ON 06/01/08. THE PATIENT INSTALLED NEW BATTERIES AND PLACED HER DEVICE IN RUN WITHOUT ERROR. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRONPLUS POWER PACK INSULIN INFUSION PUMP BATTERY LZG DISETRONIC MEDICAL SYSTEMS NA 06110273

    Patients

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