BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3014193 · Received March 21, 2013

    Report

    Report Number
    2183996-2013-00467
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 7, 2012
    Report Date
    April 17, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1646-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CAN BE VERIFIED. RESULT THE DOWN BUTTON DOES NOT OPERATE. THE CONNECTIONS OF THE DOWN FLEX PRINT ARE INTERRUPTED. THE UP BUTTONS FUNCTION WAS TESTED SUCCESSFUL AND COMPLY WITH THE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PATIENT REPORTED THE UP BUTTON ON THE INFUSION DEVICE DOES NOT WORK. PATIENT STATED THE FAILURE IS CONSTANT. PATIENT REPORTED THE BUTTON HAS NOT WORKED SINCE (B)(6) 2012. PATIENT STATED THE BUTTON DOES NOT WORK IF PRESSED HARD AND DOES NOT MAKE AN AUDIBLE BEEP WHEN PRESSED. PATIENT STATED THE BUTTON IS RAISED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117865 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR INSULIN TYPE NOT OBTAINED