BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3001174 · Received March 13, 2013

    Report

    Report Number
    2183996-2013-00384
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    October 1, 2012
    Report Date
    May 2, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE, MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE PUMP ELECTRONICS. THE BUTTONS PASSED THE FUNCTIONAL INVESTIGATION SUCCESSFULLY AND COMPLY WITH THE SPECIFICATIONS. THE UP AND DOWN BUTTONS PRODUCE AUDIBLE FEEDBACK.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE UP/DOWN BUTTONS ON THE INFUSION DEVICE WORK INTERMITTENTLY AND THE PROTECTIVE RUBBER IS SPLIT AND WEARING OUT. THE BUTTONS ARE ALMOST FLAT, HAVE TO BE PRESSED LONGER THAN NORMAL TO RESPOND, AND THE AUDIBLE RESPONSE IS NOT AS LOUD. SHE CHANGED THE BATTERY ON (B)(6) 2013, BUT THIS DID NOT RESOLVE THE ISSUE. PATIENT WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE, AND THE ALLEGED INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106061 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR HUMALOG