BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-HBS IMMUNOASSAY

    MDR report key: 7310039 · Received March 2, 2018

    Report

    Report Number
    1823260-2018-00637
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 2, 2018
    Report Date
    April 2, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOM
    PMA / PMN Number
    P010054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A NEW SAMPLE FROM THE PATIENT WAS TESTED ON (B)(6) 2018. THE AHBS RESULTS WERE 221.4 MIU/ML AND 207.7 MIU/ML. THE A-HBSII RESULTS WERE 7.58 MIU/ML AND 8.52 MIU/ML.

    Additional Manufacturer Narrative · 0

    AS NO SAMPLE FROM THE PATIENT COULD BE PROVIDED FOR FURTHER INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A GENERAL PRODUCT PROBLEM WAS EXCLUDED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED ERRONEOUS RESULTS WHEN TESTED WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4). AT 11:04 A.M., A CAPILLARY BLOOD SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 3.8 INR. AT 11:09 A.M., A CAPILLARY BLOOD SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 1.7 INR. AT 11:17 A.M., A CAPILLARY BLOOD SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING AS 4.0 INR. EACH SAMPLE WAS COLLECTED FROM A DIFFERENT FINGER. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE PATIENT'S THERAPEUTIC RANGE IS 1.0 - 3.0 INR. THE PATIENT IS TESTED DAILY IN ORDER TO MAKE MEDICATION ADJUSTMENTS. THE PATIENT'S PRODUCT WAS REQUESTED FOR INVESTIGATION. RELEVANT RETENTION TEST STRIPS (LOT 244034) WERE TESTED IN COMPARISON WITH THE MASTER LOT TEST STRIPS. FOR THIS PURPOSE TWO HUMAN BLOOD SAMPLES FROM MARCUMAR DONORS AND TWO INTERNAL REFERENCE METERS WERE USED. NO ERROR MESSAGES OCCURRED. RETENTION SAMPLES WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153503 ELECSYS ANTI-HBS IMMUNOASSAY TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ROCHE DIAGNOSTICS NA 275338

    Patients

    Seq Age Sex Outcome Treatment
    1