BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT 25-OH VITAMIN D

    MDR report key: 2883934 · Received December 21, 2012

    Report

    Report Number
    3002809144-2012-00176
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MRG
    PMA / PMN Number
    K110619
    Removal / Correction Number
    3002809144-12/17/12-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW, IT WAS DETERMINED THAT THIS ISSUE IS NO LONGER RELATED TO CORRECTION AND REMOVAL NUMBER 3002809144-12/17/12-001-C.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION/REMOVAL REPORTING NUMBER: 3002809144-12/17/12-001-C. PRODUCT EVALUATION IDENTIFIED A PRODUCT DEFICIENCY WITH THE ARCHITECT 25-OH VITAMIN D ASSAY. THE INVESTIGATION DETERMINED THAT CERTAIN REACTION VESSEL (RV) LOTS (AFFECTED RVS) MAY CAUSE CALIBRATION FAILURES OR CONTROLS OUT OF RANGE. IF AN UNAFFECTED RV LOT WAS USED TO CALIBRATE WHILE AN AFFECTED RV LOT WAS USED TO TEST THE PATIENT SAMPLES, FALSELY DEPRESSED RESULTS COULD OCCUR. IF AN AFFECTED RV LOT WAS USED TO CALIBRATE WHILE AN UNAFFECTED RV LOT WAS USED TO TEST THE PATIENT SAMPLES OR IF AN AFFECTED RV LOT WAS USED TO CALIBRATE AND TEST PATIENT SAMPLES, FALSELY ELEVATED RESULTS COULD OCCUR. THE ARCHITECT 25-OH VITAMIN D CONJUGATE HAS BEEN IDENTIFIED AS THE COMPONENT STICKING TO THE AFFECTED RV LOTS, SPECIFICALLY BIOTIN. NO OTHER ARCHITECT ASSAYS USE BIOTIN IN THE CONJUGATE. ALL ARCHITECT 25-OH VITAMIN D LOTS ARE IMPACTED IN THE SAME MANNER WHEN USING AFFECTED RVS. THERE IS NO PRODUCT PERFORMANCE ISSUE WITH THE VITAMIN D ASSAY WHEN USING THE UNAFFECTED RV LOTS. ANALYTICAL CHEMISTRY TESTING HAS SHOWN THERE IS UNIQUE MATERIAL ON THE AFFECTED RVS THAT IS NOT ON THE UNAFFECTED RVS. A PRODUCT CORRECTION LETTER HAS BEEN SENT TO ALL CURRENT ARCHITECT 25-OH VITAMIN D CUSTOMERS WHO ALSO WERE SHIPPED ANY OF THE IMPACTED RV LOTS. THIS APPROACH WILL REQUIRE COUNTRIES TO IDENTIFY LOCAL DISTRIBUTORS WHO DISTRIBUTED BOTH VITAMIN D AND IMPACTED RVS THEY WILL BE INSTRUCTED TO: DESTROY THE AFFECTED ARCHITECT RV LOTS IF THEY DO NOT HAVE ANOTHER LOT OF RVS, THEY WILL BE INSTRUCTED NOT TO USE THE AFFECTED RV LOTS WITH ARCHITECT 25-OH VITAMIN D UNTIL THEY RECEIVE REPLACEMENT MATERIAL INITIATE A QUALITY DIRECTIVE WITH Q&A TO ASSIST CUSTOMERS WHO CALL IN WITH COMPLAINTS FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CALIBRATION FAILURE WITH A CALIBRATION ERROR WHEN USING THE ARCHITECT VITAMIN.D REAGENT. NO DISCREPANT PATIENT RESULTS WERE GENERATED AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT 25-OH VITAMIN D MRG ABBOTT GERMANY 02012G000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR 03M74-02, SN (B)(4)| ARCHITECT I2000SR 03M74-02, SN (B)(4)