BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1033342 · Received April 23, 2008

    Report

    Report Number
    2183996-2008-00567
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 30, 2008
    Report Date
    April 8, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE BEGAN EXPERIENCING ELEVATED BLOOD GLUCOSE 10 DAYS AGO. SHE STATED THAT 1 WEEK AGO SHE RECEIVED AN 86 ALARM (8 WEEKS LEFT OF RUN TIME) ON THE INFUSION DEVICE AND WONDERED IF HER ELEVATED BLOOD GLUCOSE COULD BE RELATED TO THIS. SHE STATED THAT ONE DAY PRIOR, HER BLOOD GLUCOSE ELEVATED TO 503 MG/DL AND SHE FELT TIRED AND HER EYES WERE DRY. SHE INJECTED 7 UNITS OF INSULIN VIA SYRINGE BECAUSE SHE WAS "SUSPICIOUS" OF THE INFUSION DEVICE. WHEN SHE WOKE UP THE FOLLOWING MORNING HER BLOOD GLUCOSE MEASURED 60 MG/DL. HER TARGET BLOOD GLUCOSE RANGE IS 60-200 MG/DL. SHE REPORTED THAT SHE RAISED THE BASAL RATES OF THE INFUSION DEVICE A "COUPLE" OF MONTHS AGO DUE TO A THYROID ISSUE. SHE STATED THAT SHE DID SEE AIR BUBBLES IN THE INSULIN CARTRIDGE. THE CARTRIDGE HAD BEEN IN USE FOR 2 DAYS. SHE WAS ADVISED TO PRIME THE BUBBLE OUT OF THE SYSTEM. SHE WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRONPLUS INSULIN INFUSION DEVICE LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

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