BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG

    MDR report key: 7967700 · Received October 15, 2018

    Report

    Report Number
    3005094123-2018-00067
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Report Date
    December 17, 2018
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    DHA
    UDI-DI
    00380740014971
    PMA / PMN Number
    K983424
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED TO THE ARCHITECT I2000SR ANALYZER LIST 03M74-02, SERIAL NUMBER (B)(4) FOR THIS ISSUE. MDR NUMBER 1628664-2018-02073 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. MDR NUMBER 3005094123-2018-00035 WAS SUBMITTED FOR THE ISSUE USING LOT 82186UI00 AND MDR NUMBER 3005094123-2018-00068 WAS SUBMITTED FOR THE ISSUE USING LOT 85141UI00.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED MULTIPLE FALSELY ELEVATED RESULTS WHILE USING ARCHITECT TOTAL B HCG REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) INITIAL 414.24 MIU/ML (POSITIVE), REPEAT LESS THAN 1.2 MIU/ML (NEGATIVE). SID (B)(6) INITIAL 1590.22 MIU/ML (POSITIVE), REPEAT LESS THAN 1.2 MIU/ML (NEGATIVE). SID (B)(6) INITIAL 1563.44 MIU/ML (POSITIVE), REPEAT LESS THAN 1.2 MIU/ML (NEGATIVE). SID NOT PROVIDED ((B)(6)) INITIAL 208.15 MIU/ML (POSITIVE), REPEAT LESS THAN 1.2 MIU/ML (NEGATIVE). SID NOT PROVIDED (AGE AND GENDER NOT PROVIDED) INITIAL 248.2 MIU/ML (POSITIVE), REPEAT LESS THAN 1.2 MIU/ML (NEGATIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808661 ARCHITECT TOTAL B-HCG B-HCG DHA A.I.D.D LONGFORD 81083UI00 00380740014971

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER| LN 03M74-02, SN (B)(4)| LN 03M74-02, SN (B)(4)