BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 2143151 · Received June 28, 2011

    Report

    Report Number
    3002809144-2011-00511
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 9, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN FILED FOR AN INTERNATIONAL PRODUCT (B)(4) THAT HAS A SIMILAR PRODUCT (B)(4) DISTRIBUTED IN THE US. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS CONDUCTED TO INVESTIGATE THIS ISSUE. SINCE NO RETURNED MATERIALS WERE AVAILABLE FOR THE EVALUATION, A RETAINED KIT OF ARCHITECT ANTI-HBC II REAGENT, LIST NUMBER 8L44-25, LOT NUMBERS 95138HN00 AND 93464HN00, WERE TESTED ON TWO INSTRUMENTS. ALL CALIBRATIONS WERE VALID AND PASSED AND VALUES OBTAINED FOR THE TESTED CONTROLS WERE WITHIN THE SPECIFICATIONS STATED IN THE PACKAGE INSERT. REPRODUCIBILITY WAS EVALUATED AND THERE WAS NO INDICATION THAT LOT NUMBER 95138HN00 DISPLAYS AN UNUSUAL PERFORMANCE. ALL VALUES OF THE POSITIVE CONTROL TESTED WITH LOT NUMBER 95138HN00 AND NO (B)(6) RESULTS WERE OBTAINED. THE CLINICAL SENSITIVITY WAS EVALUATED WITH NO ISSUES IDENTIFIED. THE COMPLAINT RECORDS FOR THE AFFECTED LOT NUMBER WERE REVIEWED WITH NO ISSUES IDENTIFIED RELATED TO THIS OBSERVATION. THE LOG FILES WERE REVIEWED AND A CHANGE WITHIN PRESSURE MONITOR SHAPE SCORE WAS OBSERVED. THE CHANGE OF PRESSURE MAY BE CAUSED BY THE INSTRUMENT OR BY SAMPLE HANDLING. THE MOST LIKELY CAUSE FOR THIS CHANGE IS INTRODUCTION OF AIR INTO THE FLUID DRIVE LINE FOR THE SAMPLE SYRINGE. BUFFER MAY BE OUT-GASSING, THE SYRINGE MAY BE LEAKING, A FITTING OR PM SENSOR MAY BE CRACKED OR LOOSE, OR THERE MAY BE A SMALL BIT OF DEBRIS ON ONE OF THE FITTING FACE SEALS. THEREFORE, THE SYSTEM HAS TO BE CHECKED FOR BUBBLES AND MAYBE SOME PARTS SHOULD BE REPLACED. A PRECISION CHECK WAS RECOMMENDED TO BE PERFORMED BY THE CUSTOMER AND THE CUSTOMER WAS REFERRED TO REVIEW LABELING FOR PROPER SAMPLE HANDLING AND PROCESSING. NO PRODUCT DEFICIENCY WAS IDENTIFIED AS A RESULT OF THE EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT SAMPLE GENERATED A FALSE (B)(6) RESULT FOR THE ARCHITECT ANTI-HBCII ASSAY. THE SAME PATIENT SAMPLE WAS REPEATEDLY (B)(6) WHEN RETESTED WITH THE SAME ANALYZER ON THE SAME DATE AND ANOTHER ARCHITECT ANALYZER THE NEXT DAY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HBC II LOM ABBOTT GERMANY 02124LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2K ISR02874