BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1041127 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00689
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    November 29, 2007
    Report Date
    April 29, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 CALLED FOR MEDICAL ADVICE. HE WAS ADVISED TO SPEAK WITH THE PHYSICIAN. HE STATED THAT HE SEEMS TO BE BUILDING A TOLERANCE TO INSULIN AND HE HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE THAT HE IS NOT ABLE TO LOWER. HE STATED THAT HIS BLOOD GLUCOSE IS ELEVATED IN THE MORNING AND AT NIGHT. ABOUT 2 DAYS PRIOR, HIS BLOOD GLUCOSE MEASURED OVER 600 MG/DL WHEN HE WOKE UP HE BOLUSED 30 UNITS OF INSULIN THROUGH HIS INFUSION DEVICE AND INJECTED 10 UNITS OF INSULIN VIA SYRINGE. HE STATED THAT BY THE EVENING HE "CRASHED" AND HIS BLOOD GLUCOSE LOWERED TO 58 MG/DL. HE ATE SNACKS AND HIS BLOOD GLUCOSE RETURNED TO NORMAL. AN HOUR BEFORE THE REPORT, HIS BLOOD GLUCOSE MEASURED 200 MG/DL AND HE BOLUSED 3 UNITS OF INSULIN. HE STATED THAT HE HAS A DR'S APPOINTMENT IN THE NEXT DAY. HE STATED HE HAD NO ISSUES WITH HIS INFUSION DEVICE. TROUBLESHOOTING DID NOT REVEAL ANY ISSUES. UPON FOLLOW UP ABOUT 6 DAYS LATER, THE PT STATED THAT HIS PHYSICIAN REFERRED HIM TO A SPECIALIST. HE STATED THAT HE FELT BETTER BUT NOT AS WELL AS HE WOULD LIKE. NO PRODUCT WILL 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 NA NA

    Patients

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