BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2232911 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02087
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 3, 2011
    Report Date
    July 11, 2011
    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
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THE INFUSION DEVICE DISPLAYED A W2 LOW BATTERY WARNING. PT CHANGED THE BATTERY AND RECEIVED ANOTHER W2 LOW BATTERY WARNING AFTER A FEW HOURS. PT CHANGED THE BATTERY AGAIN, AND A FEW HOURS LATER, THE INFUSION DEVICE DISPLAY WAS BLANK AND THE INFUSION DEVICE WAS GIVING AN ACOUSTIC ALERT. PT DOES NOT KNOW WHAT TYPE OF ALERT WAS DISPLAYED WHEN THE SCREEN WAS BLANK, AND PT DOES NOT KNOW IF THE INFUSION DEVICE WENT INTO THE STOP MODE WHEN THE ALERT WAS TRIGGERED. PT REPLACED THE BATTERY AGAIN, AND THE INFUSION DEVICE STARTED AS NORMAL. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS EVALUATED, AND THE COMPLAINT WAS VERIFIED. E8 POWER INTERRUPT AND W2 LOW BATTERY ERRORS WERE FOUND IN THE HISTORY. THE ELECTRONIC COMPARTMENT WAS VISUALLY INSPECTED, AND THE ACID OF THE SUPER-CAP LEAKED OUT AS A RESULT OF A MANUFACTURING ERROR. THEREFORE, THE SUPER-CAP AND THE SURROUNDING ELECTRONIC PARTS ARE CORRODED. THIS LED TO HIGHER POWER CONSUMPTION OF THE INFUSION DEVICE, AND THIS WAS WHY THE INFUSION DEVICE TRIGGERED AN E2 BATTERY DEPLETED ERROR BEFORE A W2 LOW BATTERY WARNING MESSAGE OCCURRED. THE INFUSION DEVICE RESTARTED IMMEDIATELY DUE TO THIS PROBLEM AND CORRECTLY DISPLAYED AN E8 POWER INTERRUPT ERROR MESSAGE. THE HISTORY ALSO SHOWED E4 OCCLUSION ERRORS, AND THE PT DID NOT ALWAYS SOLVE THE E4 ERRORS CORRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN