BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 974358 · Received January 4, 2008

    Report

    Report Number
    2183996-2007-01920
    Event Type
    Injury
    Date Received
    January 4, 2008
    Date of Event
    December 24, 2007
    Report Date
    December 24, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2007, THE PATIENT REPORTED THAT HE RECEIVED AN 09 (TECHNICAL INSPECTION DUE) ALERT BUT HE DID NOT RECEIVE THE PRIOR 8X (88, 86, 84, 82) ALERTS WARNING HIM THAT THE INFUSION DEVICE WOULD SOON SHUT DOWN. HE STATED THAT HIS BLOOD GLUCOSE MEASURES "HI" (OVER 500 MG/DL) ON HIS BLOOD GLUCOSE MONITOR AND HE FEELS "LISTLESS." HE STATED THAT HIS BLOOD GLUCOSE TYPICALLY MEASURES 140-200 MG/DL. HE STATED THAT HE DOES HAVE A BACKUP INFUSION DEVICE. UPON FOLLOW UP THREE DAYS LATER, THE PATIENT STATED THAT HE SWITCHED TO HIS BACK UP INFUSION DEVICE AND HIS BLOOD GLUCOSE HAD DECREASED TO THE NORMAL RANGE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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, INC. NA NA

    Patients

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