BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 3812452 · Received May 15, 2014

    Report

    Report Number
    3008344661-2014-00023
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    P050051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AGAINST AN EX-US PRODUCT ((B)(4)) WHICH HAS A SIMILAR PRODUCT ((B)(4)) DISTRIBUTED IN THE US. (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. NO PATIENT SAMPLE WAS AVAILABLE FOR RETURN. CLINICAL SPECIFICITY TESTING OF NEGATIVE CONTROL REPLICATES USING AN IN-HOUSE RETAINED KIT OF LOT 34056LF00 STORED AT THE RECOMMENDED STORAGE CONDITION WAS PERFORMED. SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. 12-MONTH TICKET SEARCHES DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR THE LIKELY CAUSE LOT 34056LF00. THERE IS NO ADVERSE TREND FOR THE PRODUCT THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION AS THE FALSE RESULT IS FOR A DISCRETE SAMPLE WHERE THE SPECIFICITY IS NOT 100%. THE OVERALL SPECIFICITY WAS ESTIMATED TO BE 99.67% (1,491/1,496) WITH A 95% CONFIDENCE INTERVAL OF 99.22% TO 99.89%. PER PRODUCT LABELING QUANTITATIVE VALUES OBTAINED USING ALTERNATIVE ASSAYS (I.E. MEIA, EIA OR RIA) MAY NOT BE EQUIVALENT AND CANNOT BE USED INTERCHANGEABLY. THE ARCHITECT (B)(6) TROUBLESHOOTING GUIDE PROVIDES THE FOLLOWING INFORMATION: CORRELATION BETWEEN DIFFERENT METHODS HAS ALWAYS BEEN A CHALLENGE FOR (B)(6) ASSAYS. HISTORICALLY, (B)(6) ASSAYS HAVE NOT CORRELATED WELL ACROSS DIFFERENT PLATFORMS. VARIATION IN SLOPE AND CONCENTRATION DIFFERENCES ARE QUITE TYPICAL OF (B)(6) METHODS. CURVE SHAPE & LINEARITY DIFFERENCES WILL ALSO IMPACT CORRELATION BETWEEN DIFFERENT PLATFORMS. PER THE ARCHITECT (B)(6) REAGENT PACKAGE INSERT, IF THE (B)(6) RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. FOR DIAGNOSTIC PURPOSES, RESULTS SHOULD BE USED IN CONJUNCTION WITH PATIENT HISTORY AND OTHER HEPATITIS MARKERS. BASED ON THE EVALUATION RESULTS, NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED TO BE RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE ((B)(4)) GENERATED FALSE (B)(6) RESULTS FOR THE ARCHITECT ANTI-HBS ASSAY COMPARED TO (B)(6) RESULTS GENERATED USING NON-ABBOTT METHODS (SIMPLE METHOD, QUICK CHASER AND ESPLINE). (B)(4). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291997 ARCHITECT ANTI-HBS ANTI-HBS LOM ABBOTT IRELAND 34056LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER LN 08C89-01 SN (B)(4)| ARCHITECT ANALYZER LN 08C89-01 SN (B)(4)