BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETI-MAK-2 PLUS ASSAY

    MDR report key: 5526859 · Received March 25, 2016

    Report

    Report Number
    9610240-2016-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2016
    Date of Event
    February 22, 2016
    Report Date
    March 21, 2016
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    LOM
    PMA / PMN Number
    P990038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTS OF PATIENT INJURY OR ILLNESS HAVE BEEN RECEIVED. NO MANUFACTURING PROBLEMS OR USE ERROR HAVE BEEN IDENTIFIED. THE DIFFERENCE IN PATIENT RESULTS OBTAINED BY THE TWO TEST SYSTEMS, SIEMENS ADVIA CENTAUR (B)(4) AND THE DIASORIN ETI-MAK-2 PLUS CAN EASILY BE EXPLAINED BY THE ANALYTICAL SENSITIVITY CLAIMS REPORTED IN THE INSTRUCTIONS FOR USE. (B)(6). THE SENSITIVITY OF THE ETI-MAK-2 PLUS ASSAY, LOT NUMBER 0710510A, HAS BEEN VERIFIED AND CONFIRMED TO BE ALIGNED WITH THE PUBLISHED CLAIM STATED IN THE INSTRUCTIONS FOR USE. THE ALGORITHM RECOMMENDED BY THE CDC FOR DIAGNOSTIC TESTING ALWAYS PRESCRIBES THE TESTING OF SEVERAL (B)(6). THE INSTRUCTIONS FOR USE ACCOMPANYING BOTH KITS STATES THE RESULTS SHOULD NOT BE USED ALONE BUT IN CONJUNCTION WITH THE PATIENT'S CLINICAL PRESENTATION AND OTHER (B)(6) MARKER RESULTS FOR THE CORRECT DETERMINATION OF (B)(6) INFECTIOUS STATUS. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DIASORIN THAT THIS PRODUCT CAUSED OR CONTRIBUTED TO ANY ALLEGED INJURY OR ILLNESS. THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MDR REGULATIONS. DEVICE EXPIRED.

    Description of Event or Problem · 1

    THE USER REPORTED ON (B)(6) 2016, A (B)(6) RESULT FOR THE ETI-MAK-2 PLUS ASSAY USING KIT LOT 0710510A. DURING A ROUTINE DIAGNOSTIC TEST PERFORMED ON (B)(6) 2016, THE PATIENT SPECIMEN WAS FOUND TO BE (B)(6) ON SIEMEN'S ADVIA CENTAUR (B)(4) ASSAY AND (B)(6) ON DIASORIN'S ETI-MAK-2 PLUS ASSAY. THE (B)(6) RESULT WAS RELEASED TO THE CLINICIAN. HOWEVER, THE PATIENT WAS NOT INFORMED OF THE (B)(6) TEST RESULT. A SECOND DRAW OF THE SAME PATIENT WAS TESTED ON (B)(6) 2016 AND FOUND TO BE (B)(6) ON SIEMEN'S ADVIA CENTAUR (B)(4) ASSAY AND (B)(6) ON DIASORIN'S ETI-MAK-2 PLUS ASSAY. LOT NUMBER 0710520A OF THE ETI-MAK-2 PLUS ASSAY WAS USED TO TEST THE 2ND PATIENT SPECIMEN BECAUSE LOT 0710510A HAD EXPIRED. THE (B)(6) RESULT WAS CONFIRMED BY THE PRESENCE OF (B)(4) DNA WHICH DETERMINED THE (B)(6) AND THE PRESENCE OF A MULTIPLE MUTATION ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181186 ETI-MAK-2 PLUS ASSAY TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM DIASORIN S.P.A. 0710510A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other