BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1192443 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01545
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 29, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED EXPERIENCING OCCLUSION (E4) ERRORS ON HER INFUSION DEVICE FOR 1 WEEK AND HER BLOOD GLUCOSE WAS ELEVATED TO 334 MG/DL. SHE ATTEMPTED TO BOLUS 6 UNITS OF INSULIN AND REC'D AN E4. THE PT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND TO BOLUS 6 UNITS OF INSULIN. SHE WAS ABLE TO DO SO WITHOUT ERROR. THE PT THEN RECONNECTED TO THE INFUSION SITE AND BOLUSED WITHOUT ERROR. SHE STATED THAT THE INSULIN CARTRIDGE HAD BEEN IN USE FOR 1 WEEK. SHE WAS ADVISED TO CHANGE THE INSULIN CARTRIDGE EVERY 6 DAYS. THE ADAPTER WAS CHANGED 2 WEEKS AGO. SHE CHANGES THE INFUSION TUBING ONCE PER WEEK AND THE INFUSION SITE EVERY 3 DAYS. SHE WAS ADVISED TO CHANGE THE INFUSION TUBING EVERY 6 DAYS. HER CURRENT INFUSION SITE WAS PLACED IN HER THIGH AND HAD BEEN IN USE FOR 1 DAY. THE PT WAS SENT AN INFUSION SET INSERTION DEVICE, INFO ON INFUSION SITE MGMT, AND AN ADAPTER. UPON F/U THE FOLLOWING MONTH, THE PT STATED THAT SHE WAS DOING WELL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

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