BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 780017 · Received November 9, 2006

    Report

    Report Number
    2183996-2006-01116
    Event Type
    Injury
    Date Received
    November 9, 2006
    Date of Event
    October 19, 2006
    Report Date
    October 20, 2006
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    WIFE OF MALE, REPORTED PT BEING DIAGNOSED WITH DKA AT THE HOSPITAL WITH A BLOOD GLUCOSE LEVEL >800 MG/DL IN 2006. SHE INDICATED THAT HIS BLOOD GLUCOSE HAD BEEN 160-260 MG/DL THE THREE DAYS PRIOR TO THE INCIDENT OF BLOOD GLUCOSE LEVEL >800 MG/DL. HIS NORMAL RANGE IS 100-150 MG/DL. WIFE INDICATED PT HAD BEEN DIAGNOSED WITH A VIRUS AND HIS INFUSION SITE HAD BEEN IN USE FOR 4-5 DAYS. ON THE DAY OF THE INCIDENT, THERE WAS NO INSULIN COMING OUT OF THE INFUSION SET TUBING. THE FOLLOWING DAY, AFTER CHANGING THE INFUSION SET AND CARTRIDGE, INSULIN DRIPPED FROM THE END OF THE TUBING. THE PISTON ROD AND ADAPTER WERE IN USE FOR MORE THAN 6 MONTHS. THE ADAPTER IS RECOMMENDED TO BE CHANGED EVERY 6 MONTHS. SHE INDICATED THAT PT NORMALLY CHANGES HIS INFUSION SET EVERY 2-3 DAYS. PT REPORTED INFUSION SET WAS NOT CHANGED AS NORMAL, DUE TO BEING SICK. HE FELT DEHYDRATED AND NOT VERY COHERENT WHEN HIS BLOOD GLUCOSE LEVEL WAS ELEVATED. PT WAS PLACED ON INSULIN DRIP UPON ADMITTANCE INTO THE HOSPITAL. ON THE SAME DAY, PT'S BLOOD GLUCOSE LEVEL WAS 110 MG/DL. TEN DAYSE LATER, AFTER RELEASE FROM THE HOSPITAL, PT INDICATED THAT HIS BLOOD GLUCOSE WAS WITHIN THE NORMAL RANGE OF 100-150 MG/DL. WIFE INDICATED THAT PT WAS INSTRUCTED TO HAVE INFUSION DEVICE INSPECTED. UPON COMPLETION OF TROUBLESHOOTING, INFUSION DEVICE WAS FOUND TO BE FUNCTIONING PROPERLY AND THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R INSULIN INFUSION SET, DATE OF TREATMENT| INSULIN,