BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 8101444 · Received November 26, 2018

    Report

    Report Number
    3005094123-2018-00178
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Report Date
    January 15, 2019
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT TRENDING REPORT DETERMINED THAT THERE ARE NO ADVERSE TRENDS FOR THE PRODUCT, HOWEVER A NON-STATISTICAL TREND WAS IDENTIFIED RELATED TO THE ISSUE UNDER REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLD WIDE DATA THROUGH ABBOTTLINK WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR LOT 85141UI00 IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD WITHIN ESTABLISHED BASELINES, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. ACCURACY TESTING WAS PERFORMED USING A RETAINED KIT OF LOT 85141UI00 AND ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PREFORMING ACCEPTABLY. A REVIEW OF THE INSTRUMENT LOG FILE CONFIRMED THE CUSTOMER'S OBSERVATION, HOWEVER, NO INSTRUMENT ISSUES WERE IDENTIFIED. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER'S OBSERVATION. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT TOTAL B-HCG, LOT 85141UI00.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER = SID (B)(6) / NEW DRAW SAME PATIENT, SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT B-HCG RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL = 9695.32MIU/ML (>/=25.0MIU/ML = POSITIVE) / NEW DRAW SAME PATIENT, SID (B)(6) RETEST = <1.5MIU/ML (</=5.0MIU/ML = NEGATIVE). THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943280 ARCHITECT TOTAL B-HCG B-HCG DHA A.I.D.D LONGFORD 85141UI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,| ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,| SERIAL # (B)(4). | SERIAL # (B)(4).