BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2803118 · Received October 19, 2012

    Report

    Report Number
    2183996-2012-01623
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 16, 2012
    Report Date
    April 16, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. PRODUCTION DATA WAS REVIEWED AND COMPLY WITH SPECIFICATIONS. THE ISSUE REPORTED BY THE PATIENT COULD NOT BE DUPLICATED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT REPORTED THE CARTRIDGES LEAK INSULIN WHILE THE INFUSION DEVICE IS IN USE. AIR BUBBLES ARE REMOVED AFTER THE CARTRIDGE IS FILLED, BUT MORE AIR BUBBLES FORM WITHIN A FEW MINUTES AND THE CARTRIDGES TO RETURN FOR EVALUATION. THE PRODUCT WAS REPLACED, AND AN EDUCATOR WILL MEET WITH THE PATIENT TO REVIEW HANDLING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006871 32464280

    Patients

    Seq Age Sex Outcome Treatment
    1 AND RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN