BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 9328816 · Received November 15, 2019

    Report

    Report Number
    3005094123-2019-00320
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    November 1, 2019
    Report Date
    February 24, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD
    Product Code
    DHA
    UDI-DI
    00380740014971
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NAME UPDATED FROM A.I.D.D LONGFORD TO ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD THE TICKET SEARCH DETERMINED ELEVATED COMPLAINT ACTIVITY FOR THE LOT. COMPLAINT TRENDING REPORT REVIEW DETERMINED THAT THERE IS NO ADVERSE TREND FOR THE PRODUCT. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. A TEST PROTOCOL WAS EXECUTED USING RETAINED SAMPLES OF ARCHITECT TOTAL B-HCG REAGENT LOT 03333UI00. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, DEMONSTRATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE PRODUCT QUALITY HISTORY FOR THE LOT NUMBER USING SEARCH OF THE CORRECTIVE AND PREVENTATIVE ACTIONS SYSTEM DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER DOES NOT CONTAIN ENOUGH SPACES. THE ENTIRE ID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSE POSITIVE ARCHITECT TOTAL BHCG OF 603.56 MIU/ML ON PATIENT SID (B)(6) THAT REPEATED NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121856 ARCHITECT TOTAL B-HCG B-HCG DHA ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD 7K78-30 03333UI00 00380740014971

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR LIST 03M74-02| ARCHITECT I2000SR LIST 03M74-02| SERIAL (B)(6)| SERIAL (B)(6)