BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2915356 · Received December 28, 2012

    Report

    Report Number
    2183996-2012-02070
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 21, 2012
    Report Date
    March 11, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. E4 OCCLUSION ERRORS WERE FOUND IN THE HISTORY, AND THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY. W1 (CARTRIDGE LOW) AND E1 (CARTRIDGE EMPTY) ERRORS WERE FOUND IN HISTORY. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED.

    Additional Manufacturer Narrative · 1

    THE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT¿S INFUSION DEVICE DID NOT DISPLAY W1 (CARTRIDGE LOW) OR E1 (CARTRIDGE EMPTY). THE PATIENT NOTICED HER INSULIN CARTRIDGE WAS EMPTY WHEN THE DEVICE DISPLAYED E4 (OCCLUSION ERROR). NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP