BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 785236 · Received November 14, 2006

    Report

    Report Number
    2183996-2006-00371
    Event Type
    Injury
    Date Received
    November 14, 2006
    Date of Event
    November 1, 2006
    Report Date
    November 3, 2006
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6-CODES: NO PRODUCT NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE FROM 340 TO 500S MG/DL FOR THE LAST 3 DAYS. THE PATIENT'S NORMAL RANGE IS 120-220 MG/DL. THE PATIENT DID NOT REPORT ANY SYMPTOMS WITH HER ELEVATED BLOOD GLUCOSE. THE PATIENT TRIED BOLUSING AND CHANGING HER TUBING AND SITE, BUT HER BLOOD GLUCOSE REMAINED ELEVATED. THE PATIENT SWITCHED TO HER BACK-UP INFUSION DEVICE AND HER BLOOD GLUCOSE RETURNED TO NORMAL. THE PATIENT DID NOT REPORT ASSISTANCE BY A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PISTON ROD AND ADAPTER WERE OVER 6 MONTHS OLD. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. 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, INC. H-TRONPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other DATE OF TREATMENT,| INSULIN INFUSION SET| INSULIN