BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3834573 · Received May 28, 2014

    Report

    Report Number
    1823260-2014-03737
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    PATIENT REPORTED THE MENU BUTTON ON THE INFUSION DEVICE STOPPED WORKING THE DAY BEFORE THE CALL. PATIENT STATED HE HAD TO MOVE TO AN ALTERNATIVE THERAPY AS A RESULT. PATIENT REPORTED THERE ARE SEVERAL E8 (POWER INTERRUPT) ERROR MESSAGES IN THE DEVICE HISTORY. PATIENT STATED HE WENT TO THE ER WHERE THEY WEREN'T ABLE TO MAKE THE INFUSION DEVICE WORK; GAVE HIM THE GUIDELINES AND THE INSULIN TO FOLLOW AN ALTERNATIVE TREATMENT. PATIENT'S BLOOD GLUCOSE LEVEL AT THE HOSPITAL WAS 360 MG/DL ON THE HOSPITAL METER. HAD PATIENT INSERT A NEW BATTERY DURING THE CALL; INFUSION DEVICE BEGAN WORKING CORRECTLY. PATIENT REPORTED THE LATERAL BUTTONS' RUBBER ON THE INFUSION DEVICE ARE BROKEN. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313841 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR