BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 2081680 · Received May 9, 2011

    Report

    Report Number
    3005094123-2011-00005
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    April 15, 2011
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    PMA / PMN Number
    K983442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLICATED ARCHITECT TSH REAGENT KIT WAS UNAVAILABLE FROM THE CUSTOMER. PRODUCT RELEASE TESTING FOR ARCHITECT TSH REAGENT LIST NUMBER 7K62-25, LOT NUMBER 94901JN00 WAS REVIEWED. THE REVIEW DEMONSTRATED THAT ALL CALIBRATIONS MET ASSAY FILE SPECIFICATIONS, CONTROL AND IN-HOUSE PANEL VALUES WERE WITHIN SPECIFICATION AND NO ADVERSE TRENDS WERE OBSERVED. ACCURACY TESTING WAS PERFORMED AND MET ACCEPTANCE CRITERIA. A REVIEW OF COMPLAINT HISTORY FOR ARCHITECT TSH REAGENT LOT 94901JN00 DID NOT IDENTIFY ANY ADVERSE TRENDS FOR PERFORMANCE RELATED ISSUES. NO DEFICIENCY RELATED TO THE PERFORMANCE OF ARCHITECT TSH REAGENT LOT 94901JN00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSELY LOW ARCHITECT TSH RESULT WAS GENERATED FOR A PATIENT SAMPLE. INITIAL TESTING WAS 12.97 MIU/L. THE SAMPLE RETESTED AT 4.07, 14 AND 14 MIU/L. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR TESTING WHICH CONFIRMED THAT THE RESULT OF 4.07 MIU/L WAS FALSELY LOW (NO EXACT VALUE PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TSH FOR THE DETERMINATION OF HUMAN THYROID STIMULATING HORMONE (TSH) JLW A.I.D.D LONGFORD 94901JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR LIST 1L86-01, SERIAL (B)(4)| ARCHITECT I1000SR LIST 1L86-01, SERIAL (B)(4)