BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1012665 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00308
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 23, 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
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED HIS BLOOD GLUCOSE ELEVATED TO 1040 MG/DL AND HE WENT INTO A DIABETIC COMA ON EIGHT DAYS EARLIER. HE STATED THAT HE WAS TAKEN BY AMBULANCE TO THE HOSPITAL AND WAS GIVEN A "BREATHING TUBE." HE WAS DIAGNOSED WITH KETOACIDOSIS. HE STATED HE "PASSED OUT FOR 5 DAYS." HE STATED THE "PUMP DIED ON ME" AND GAVE "NO WARNING, FOR SOME REASON I WASN'T GETTING INSULIN." HE THEN STATED LATER IN THE CONVERSATION "MAYBE IT WASN'T THE PUMP." HE RECONNECTED TO THE INFUSION DEVICE ON TWO DAYS PRIOR TO ORIGINAL DATE, AND HIS BASAL RATES WERE INCREASED TO 0.1 UNITS OF INSULIN PER HOUR. HE STATED THE INFUSION DEVICE WAS "KIND OF WORKING, BUT IT WASN'T WORKING." HIS BLOOD GLUCOSE STAYED BETWEEN 200-230 MG/DL. HE WAS RELEASED FROM THE HOSPITAL ON ORIGINAL DATE. HIS TARGET BLOOD GLUCOSE LEVEL IS 100 MG/DL. HE DISCONTINUED USE OF THE INFUSION DEVICE ON THE NEXT DAY. HE HAS BEEN ON INJECTION THERAPY SINCE ONE DAY LATER. HE STATED THAT THIS MORNING HIS BLOOD GLUCOSE MEASURED 238 MG/DL AND HE INJECTED 8 UNITS OF INSULIN. AT 10:00AM HIS BLOOD GLUCOSE MEASURED 349 MG/DL AND HE INJECTED ANOTHER 8 UNITS OF INSULIN. TROUBLESHOOTING DID NOT REVEAL ANY ISSUES. HE STATED HIS INFUSION SITES ARE "WORN OUT." HE REPORTED EXPERIENCING OCCLUSION (04) ERRORS FOR 2 WEEKS TO 10 DAYS PRIOR TO HOSPITALIZATION. HE STATED THE OCCLUSION DID NOT AFFECT HIS BLOOD GLUCOSE AND HE WAS ABLE TO CLEAR THE ERRORS BY CHANGING THE INFUSION SITE AND INFUSION TUBING. PRODUCT WAS REPLACED AND REQUESTED TO 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 Hospitalization| O| R INSULIN| INSULIN INFUSION SET