BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-TRONPLUS

    MDR report key: 829467 · Received March 14, 2007

    Report

    Report Number
    2183996-2007-00279
    Event Type
    Injury
    Date Received
    March 14, 2007
    Date of Event
    January 26, 2007
    Report Date
    February 26, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAS BEEN GETTING ELEVATED BLOOD GLUCOSE VALUES (250-499 MG/DL) OVER THE PAST MONTH. HE STATED THAT HE BELIEVES THE INFUSION DEVICE IS NOT FUNCTIONING PROPERLY. HE REPORTED THAT HE HAS SWITCHED BACK TO INJECTIONS AND HIS BLOOD GLUCOSE VALUES HAVE RETURNED BACK TO NORMAL (100-160 MG/DL). THE PT REPORTED EXPERIENCING NAUSEA AND FATIGUE WITH THE ELEVATED BLOOD GLUCOSE VALUES. THE PATIENT DID REPORT THAT HE WAS ALSO EXPERIENCING 04 (OCCLUSION) ALARMS AND AT TIMES COULD SMELL INSULIN BUT COULD NOT FIND ANY EVIDENCE OF LEAKAGE. THE PATIENT DID NOT REPORT REQUIRING MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention INSULIN INFUSION SET| INSULIN