BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3242264 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01341
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 16, 2013
    Report Date
    September 6, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. E2, A2 AND E8 ERRORS WERE FOUND IN THE HISTORY LIST. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY; THEREFORE, MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE PUMP ELECTRONICS. THE BUTTONS WERE TESTED SUCCESSFULLY AND THE FUNCTIONALITY FULFILLS THE PRODUCT SPECIFICATIONS. THE PUMP CORRECTLY TRIGGERED AN E8 ERROR AS A RESULT OF THE POWER INTERRUPTION WHILE THE PUMP WAS IN RUN MODE. ALSO THE A2 ALERT WAS CORRECTLY TRIGGERED WHEN THE BATTERY WENT EMPTY. DUE TO THE EMPTY BATTERY, THE PUMP CORRECTLY TRIGGERED THE E2 ERROR MESSAGE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE BUTTONS ON THE INFUSION DEVICE ARE UNRESPONSIVE. HE RECEIVED AN E2 BATTERY DEPLETED ERROR EARLIER IN THE DAY, AND WHEN HE PRESSED THE CHECK BUTTON TO CONFIRM THE ERROR, AND E8 POWER INTERRUPT ERROR WAS DISPLAYED. AN UNEXPIRED ALKALINE BATTERY WAS IN USE, AND THE BATTERY COVER WAS NOT DAMAGED. HE DOES NOT BELIEVE THE INFUSION DEVICE DISPLAYED AN A2 BATTERY LOW ALERT PRIOR TO THE ERROR MESSAGE. THE INFUSION DEVICE WAS NOT DROPPED WITHIN THE PREVIOUS 48 HOURS. THE BATTERY AND BATTERY COVER WERE REPLACED DURING THE TROUBLESHOOTING CALL, BUT THIS DID NOT RESOLVE THE ISSUE. THE INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE 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
    343287 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR HUMALOG| BABY ASPRIN| ATORVASTATIN| LOSARTANPOT