BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1063141 · Received June 20, 2008

    Report

    Report Number
    2183996-2008-00930
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 12, 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
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE RECEIVED AN E6 (MECHANICAL) ERROR ON HER INFUSION DEVICE. SHE STATED THAT SHE ALSO RECEIVED THE ERROR THE PREVIOUS DAY AND WAS ABLE TO CLEAR THE ERROR BY CHANGING THE INSULIN CARTRIDGE AND INSERTING A NEW BATTERY. TO TROUBLESHOOT THE PATIENT WAS INSTRUCTED TO PERFORM THE CHANGE CARTRIDGE PROCEDURE, SHE WAS USING A CARTRIDGE FILLED WITH WATER. SHE WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY AND INSERTED A CARTRIDGE FILLED WITH INSULIN. DURING PRIMING PROCESS, SHE RECEIVED AN E4 (OCCLUSION) ERROR. SHE WAS INSTRUCTED TO CHANGE THE INFUSION TUBING. THE PATIENT SUCCESSFULLY PRIMED THE INFUSION TUBING AND WAS ABLE TO CLEAR THE E6 AND E4 ERRORS. THE PATIENT STATED THAT SHE FELT AS IF HER BLOOD GLUCOSE WAS ELEVATED BECAUSE SHE "HAD A FUNNY TASTE IN HER MOUTH AND HAS BEEN DRINKING LOTS OF WATER." THE PATIENT HAD NOT TESTED HER BLOOD GLUCOSE. SHE INJECTED 14 UNITS OF INSULIN VIA SYRINGE. FURTHER ATTEMPTS TO FOLLOW UP WITH THE PATIENT WERE UNSUCCESSFUL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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