BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3905117 · Received July 1, 2014

    Report

    Report Number
    1823260-2014-04783
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    January 6, 2014
    Report Date
    August 11, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER STATED THE BUTTONS ON THE INFUSION DEVICE HAVE NOT FUNCTIONED CORRECTLY SINCE (B)(6), 2014, AND THE ISSUE HAS BECOME PROGRESSIVELY WORSE. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL DUE TO HYPERGLYCEMIA ON (B)(6) 2014, AND THE REPORTER STATED THIS WAS CAUSED BY NOT BEING ABLE TO BOLUS VIA THE INFUSION DEVICE AND BY A URINARY TRACT INFECTION. THE CUSTOMER'S BLOOD GLUCOSE ELEVATED ABOVE 500 MG/DL, AND HER NORMAL RANGE IS 80-120 MG/DL. THE CUSTOMER DROVE HERSELF TO THE HOSPITAL, AND SHE WAS ADMITTED UNTIL (B)(6) 2014 AND TREATED WITH AN IV. HER BLOOD GLUCOSE HAS RETURNED TO NORMAL SINCE BEING DISCHARGED, AND SHE HAS CONTINUED TO USE THE INFUSION DEVICE. THE PROTECTIVE RUBBER HAS WORN OFF SOME BUTTONS AND THE METAL GROUND-PLATE IS EXPOSED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384981 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 073 YR Hospitalization| R HUMALOG| AVIVA BLOOD GLUCOSE MONITOR