BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SHBG

    MDR report key: 6552913 · Received May 8, 2017

    Report

    Report Number
    3002809144-2017-00034
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    April 10, 2017
    Report Date
    May 8, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    CDZ
    PMA / PMN Number
    K060818
    Removal / Correction Number
    3002809144-04/18/17-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 3002809144-04/18/17-001-C WAS TOO LONG TO FIT IN SECTION. A PRODUCT CORRECTION LETTER WAS ISSUED TO ALL CUSTOMERS WHO RECEIVED ONE OR MORE OF THE ARCHITECT SHBG REAGENT LOTS LISTED BELOW. THE CUSTOMERS WERE INSTRUCTED TO IMMEDIATELY DISCONTINUE USE OF POTASSIUM EDTA SPECIMEN TUBE TYPES WITH THE ARCHITECT SHBG ASSAY. A KIT STUFFER WILL BE INCLUDED WITH ALL CURRENT INVENTORY ADVISING THE CUSTOMER TO DISCONTINUE THE USE OF POTASSIUM EDTA TUBE TYPES. THE REAGENT PACKAGE INSERT FOR ALL FUTURE LOTS OF ARCHITECT SHBG HAS BEEN UPDATED TO REMOVE POTASSIUM EDTA TUBES AS AN ACCEPTABLE TUBE TYPE FOR SPECIMEN COLLECTION. ALL IN-DATE ARCHITECT SHBG LOT NUMBERS ARE IMPACTED AS FOLLOWS: LIST NUMBER, LOT NUMBER, MANUFACTURE DATE, EXPIRATION DATE 8K26-20, 01916E000, 13-JUN-2016, 25-APR-2017 8K26-20, 00316F000, 04-JUL-2016, 27-MAY-2017 8K26-20, 01816G000, 31-AUG-2016, 12-JUL-2017 8K26-20, 00916I000, 05-OCT-2016, 05-SEP-2017 8K26-20, 07316I000, 07-DEC-2016, 21-OCT-2017 8K26-20, 00916L000, 20-JAN-2017, 16-DEC-2017 8K26-25, 01816E000, 13-JUN-2016, 25-APR-2017 8K26-25, 00216F000, 04-JUL-2016, 27-MAY-2017 8K26-25, 01716G000, 31-AUG-2016, 12-JUL-2017 8K26-25, 00816I000, 05-OCT-2016, 05-SEP-2017 8K26-25, 07216I000, 07-DEC-2016, 21-OCT-2017

    Description of Event or Problem · 1

    ABBOTT LABORATORIES HAS IDENTIFIED A POTENTIAL FOR FALSELY DECREASED ARCHITECT SHBG RESULTS TO BE GENERATED WHEN USING THE ARCHITECT SHBG ASSAY WITH THE POTASSIUM EDTA SPECIMEN TUBE TYPE. THIS MAY ALSO RESULT IN AN INCREASE IN FREE ANDROGEN INDEX / FREE TESTOSTERONE INDEX CALCULATIONS OF UP TO 30% WHEN USING POTASSIUM EDTA SPECIMEN TUBES.NO PATIENT INJURY HAS BEEN REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332932 ARCHITECT SHBG TESTOSTERONE TEST SYSTEM CDZ ABBOTT GERMANY

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ISYSTEM ANALYZER