BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 2950853 · Received February 8, 2013

    Report

    Report Number
    3005094123-2013-00002
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 14, 2013
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A REVIEW OF ALL COMPLAINTS ASSOCIATED WITH THE ARCHITECT TSH ASSAY (LN 7K62) AND THE ARCHITECT TSH ASSAY REAGENT LOT 20927JN00 WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ATYPICAL COMPLAINT ACTIVITY. A REVIEW WAS ALSO CONDUCTED TO DETERMINE IF ANY KNOWN QUALITY ISSUES HAVE BEEN OBSERVED PERTAINING TO THIS MATERIAL. THE REVIEW DETERMINED THAT THERE WERE NO OCCURRENCES OF DEVIATIONS OR NON-CONFORMANCES FOR THIS LOT OF MATERIAL. A REVIEW OF PRODUCT LABELING INDICATES THAT FALSE DEPRESSED RESULTS AS OUTLINED ABOVE MAY BE ATTRIBUTED TO ANY LIMITATION OF THE ASSAY AS OUTLINED IN THE ARCHITECT TSH PACKAGE INSERT (49-3481/R3).THERE IS SUFFICIENT LABELING TO AID THE CUSTOMER IN THIS OBSERVATION. THE INVESTIGATION DETERMINED THAT THERE IS NO MALFUNCTION OR DEFICIENCY ASSOCIATED WITH ARCHITECT TSH, LIST 7K62, LOT 20927JN00.

    Description of Event or Problem · 1

    AN ARCHITECT TSH RESULT OF 0.083947 MIU/ML WAS GENERATED FOR A PATIENT SAMPLE ON (B)(6) 2013 AND REPORTED OUT OF THE LABORATORY AS <0.15 MIU/ML. THE SAME PATIENT SAMPLE WAS RETESTED ON (B)(6) 2013 AFTER BEING QUESTIONED BY A PHYSICIAN. THE RETEST RESULT WAS 0.5956 MIU/ML. THE PATIENT WAS REDRAWN AND THE ARCHITECT TSH RESULT WAS 0.63 MIU/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54991 ARCHITECT TSH JLW A.I.D.D LONGFORD 20927JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER| LIST 01L86-40, SERIAL (B)(4)| LIST 01L86-40, SERIAL (B)(4)| ARCHITECT I1000SR ANALYZER