BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2143714 · Received June 3, 2011

    Report

    Report Number
    2183996-2011-01584
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    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
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE RANGING FROM 14.5-33.2 MMOL/L (261-598 MG/DL) FROM 10 AM - 12:10 PM ON (B)(6) 2011. SHE CONTACTED HER DIABETES EDUCATOR AND WAS ADVISED TO INJECT 8 UNITS OF INSULIN AT 10:30 AM AND AGAIN AT 11:15 AM AND HER BLOOD GLUCOSE DECREASED. SHE STATED, SHE CHANGES HER INFUSION SITE CORRECTLY AND PRACTICES PROPER SITE ROTATION. THE PT WAS INSTRUCTED TO DISCONNECT FROM THE INFUSION SITE AND SHE PRIMED 1 UNIT OF INSULIN WITHOUT ERROR. SHE REPORTED EXPERIENCING SIMILAR ISSUES IN (B)(6) 2011 (NO DETAILS PROVIDED). THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR INSULIN| INSULIN INFUSION SET