BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2081550 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00989
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 4, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION DEVICE WAS THOROUGHLY EVALUATED. THE DISPLAY IS BROKEN AND IS PARTIALLY UNREADABLE. THE DAMAGE WAS CAUSED BY A MECHANICAL IMPACT. THE E7 (MECHANICAL) ERROR WAS FOUND IN THE DEVICE HISTORY. THE ERROR MESSAGE IS A SEQUENCE ERROR OF MECHANICAL IMPACT. THE RESISTOR ON THE POWER SUPPLY BOARD IS DEFECTIVE. AS A RESULT THE ERROR IS UNRESOLVABLE. THE ISSUE IS RELATED TO USER HANDLING.

    Description of Event or Problem · 1

    THE PT RECEIVED AN E7 ELECTRONIC ERROR ON THE INFUSION DEVICE. A NEW BATTERY WAS INSERTED, BUT THIS DID NOT RESOLVE THE ISSUE. PT REMOVED AND REINSERTED THE SAME NEW BATTERY, AND THE ERROR MESSAGE CLEARED AND THEN REAPPEARED. HE REMOVED AND REINSERTED THE BATTERY AGAIN, BUT THE INFUSION DEVICE DISPLAY WAS BLANK. THE INFUSION DEVICE CONTINUED TO BEEP. E7 ELECTRONIC ERROR APPEARED WHILE THE INFUSION DEVICE WAS IN BASAL RATE DELIVERY. THE INFUSION DEVICE WAS NOT EXPOSED TO WATER, ELECTROMAGNETIC FIELDS, OR TEMPERATURE CHANGES, AND THE CORRECT TYPE OF BATTERY WAS USED. INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE WITHIN THE PAST 48 HOURS. INFUSION DEVICE WAS 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR INSULIN INFUSION SET| INSULIN