BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3143426 · Received June 3, 2013

    Report

    Report Number
    2183996-2013-01000
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    August 12, 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
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS. RESULT AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. AS THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE INFUSION DEVICE SHOWS AN E8 (POWER INTERRUPT) ERROR MESSAGE. PATIENT STATED NO BUTTON WILL RESPOND. PATIENT REPORTED SHE WENT TO DO A BOLUS AND NOTHING HAPPENED. PATIENT STATED THE BUTTONS WOULD NOT RESPOND TO HER PRESSING THEM. PATIENT REPORTED THIS HAS NEVER OCCURRED BEFORE. PATIENT STATED SHE TRIED TO PRESS ANY BUTTON AND NOTHING HAPPENED. PATIENT REPORTED SHE REMOVED AND REINSERTED THE BATTERY AND THEN RECEIVED THE E8 AGAIN. ADVISED TO REMOVE THE BATTERY AND GET A NEW ONE. PATIENT STATED THE INFUSION DEVICE POWERS ON, GOES THROUGH SELF-CHECK, AND THEN SHOWS E7 (ELECTRONIC ERROR) MESSAGE. ADVISED TO REMOVE THE BATTERY ONE MORE TIME AND REINSERT; INFUSION DEVICE SHOWS E8 AGAIN. PATIENT REPORTED THE FAILURE IS CONSTANT AND THE BUTTONS JUST STOPPED RESPONDING TODAY. PATIENT WILL GO ON INJECTION THERAPY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE, BATTERY, AND BATTERY COVER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244634 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR HUMALOG INSULIN