BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT ADAPTER

    MDR report key: 1014081 · Received March 14, 2008

    Report

    Report Number
    2183996-2008-00339
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED, HE BEGAN TO SMELL INSULIN AND HIS BLOOD GLUCOSE WAS ELEVATED TO 275 MG/DL. HE STATED HE DISCOVERED HIS ADAPTER WAS LEAKING INSULIN. HE EXAMINED THE ADAPTER AND STATED IT APPEARED TO BE NORMAL. THE ADAPTER WAS CHANGED ON THE DAY BEFORE. THE PT CHANGED THE ADAPTER AND INFUSION TUBING. HE THEN PERFORMED A PRIME AND NO INSULIN LEAKED FROM THE ADAPTER. HE ATTRIBUTED ELEVATED BLOOD GLUCOSE TO STRESS, MEDICATION, AND PAIN FROM RECENT KNEE SURGERY. HE STATED, HE HAS A SKIN INFECTION FROM SURGERY AND HIS PHYSICIAN HAS ADVISED HIM TO CHANGE HIS INFUSION SITE DAILY. UPON FOLLOW UP ON THREE DAYS AFTER THE ORIGINAL DATE, THE PT STATED HIS BLOOD GLUCOSE IS STILL SLIGHTLY ELEVATED AT 175 MG/DL DUE TO MEDICATION. HE STATED HE HAS NO FURTHER ISSUES WITH ADAPTERS LEAKING INSULIN. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT ADAPTER INSULIN INFUSION PUMP ADAPTER LZG DISETRONIC MEDICAL SYSTEMS NA 07020066

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN| INSULIN INFUSION PUMP