BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT INSULIN

    MDR report key: 1047964 · Received May 15, 2008

    Report

    Report Number
    1415939-2008-00064
    Event Type
    Other
    Date Received
    May 15, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CEP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (INVESTIGATION IN PROCESS, NO CONCLUSION CAN BE DRAWN). THIRD PARTY RELATIONSHIP: ABBOTT LABORATORIES, ABBOTT DIAGNOSTICS DIVISION, HAS ENTERED INTO AN AGREEMENT WITH DENKA SEIKEN CO. LTD FOR THE MFR OF THE ARCHITECT INSULIN ASSAY. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A ARCHITECT INSULIN RESULT OF 70 UU/ML ON A SPECIMEN THAT TESTED AXSYM INSULIN OF 40 UU/ML. THE ACCOUNT IS QUESTIONING THE HIGH ARCHITECT INSULIN RESULT. THE ARCHITECT INSULIN RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT INSULIN CMIA QUANTITATION OF HUMAN INSULIN CEP ABBOTT LABORATORIES NA 60020LP18

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ARCHITECT LIST 8C89-01