BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2800097 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01598
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 15, 2012
    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
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    MOTHER REPORTED THE PT EXPERIENCED HYPERGLYCEMIA FOR THE PAST WEEK, AND SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. AT TIMES, HIS BLOOD GLUCOSE HAS ELEVATED ABOVE 420 MG/DL. THE INFUSION DEVICE WAS REQUESTED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP