BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1033715 · Received April 25, 2008

    Report

    Report Number
    2183996-2008-00587
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 27, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT HER BLOOD GLUCOSE HAS BEEN ELEVATED TO 400 MG/DL FOR THE PAST "MONTH AND A HALF." SHE STATED THAT THE ELEVATED BLOOD GLUCOSE OCCURS ONCE PER WEEK AT NIGHT. HER NORMAL BLOOD GLUCOSE RANGE IS 125-150 MG/DL. SHE STATED THAT SHE IS TYPICALLY ABLE TO BOLUS TO LOWER HER BLOOD GLUCOSE. ON THE SAME DAY, HER BLOOD GLUCOSE ELEVATED TO 325 MG/DL AND SHE BOLUSED 4 UNITS OF INSULIN FOR HER MEAL, AND AN ADDITIONAL 4 UNITS OF INSULIN FOR ELEVATED BLOOD GLUCOSE. TWO HOURS LATER, HER BLOOD GLUCOSE MEASURED 322 MG/DL AND SHE BOLUSED ANOTHER 4 UNITS OF INSULIN. AT THE TIME OF THE REPORT, SHE STATED THAT SHE HAD NOT YET TESTED HER BLOOD GLUCOSE BUT SHE FELT MUCH BETTER. THE TIME ON HER INFUSION DEVICE WAS NOT SET CORRECTLY. TROUBLESHOOTING DID NOT REVEAL ANY FURTHER ISSUES. SHE WAS ADVISED TO CONTACT HER PHYSICIAN. UPON FOLLOW UP ON THE FOLLOWING MONTH, THE PT REPORTED THAT SHE WAS ADVISED BY HER PHYSICIAN TO DISCONTINUE USE OF THE INFUSION DEVICE. SHE SWITCHED TO INJECTION THERAPY AND STATED HER BLOOD GLUCOSE WAS "FINE." PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN