BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M EBV AMP KIT

    MDR report key: 18817500 · Received March 1, 2024

    Report

    Report Number
    3005248192-2024-00055
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 19, 2024
    Report Date
    June 10, 2024
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QLX
    PMA / PMN Number
    K212778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: RETAIN SAMPLE EVALUATION THE FILE SAMPLE TESTING DID NOT IDENTIFY A PRODUCT DEFICIENCY FOR THE ALINITY M EBV AMP KIT (LIST 09N43-095) LOT 391395. NO ERROR CODES OR FLAGS WERE OBSERVED FOR ALL THE SAMPLES. THE RUN PASSED THE VALIDITY AND ACCEPTANCE CRITERIA ESTABLISHED. CUSTOMER DATA REVIEW: CUSTOMER RESULT LOG FILES WERE REVIEWED. THE RUNS WHICH INVOLVED THE DISCREPANT RESULT WERE VALID AND MET ASSAY SPECIFICATION REQUIREMENTS. THE VALIDITY OF THE RUN MET ASSAY SPECIFICATION REQUIREMENTS. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FROM THIS ANALYSIS. QUALITY DATA REVIEW DEVICE HISTORY RECORD / BATCH RECORD REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ALINITY M EBV AMP KIT (LIST 09N43-095) LOT 391395 (INCLUDING THE COMPONENTS) WAS PERFORMED. THE MANUFACTURING PACKETS WERE REVIEWED TO IDENTIFY ANY ISSUES RELATED TO THE REPORTED COMPLAINT DURING PRODUCTION OF THE LOT COMPONENTS. NO ISSUES WERE IDENTIFIED. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. CAPA / NON-CONFORMANCE REVIEW: THE CAPA REVIEW FOR ALINITY M EBV AMP KIT (LIST 09N43-095) LOT 391395 (INCLUDING THE COMPONENTS) WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE SEARCH DID NOT IDENTIFY ANY RECORDS RELATED TO THE REPORTED ISSUE FOR THESE LOTS. COMPLAINT HISTORY REVIEW A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED, WHICH REPORTED A DISCREPANT RESULT WHILE ALINITY M EBV AMP KIT (LIST 09N43-095) LOT 391395. NO NEW ADVERSE TREND WAS IDENTIFIED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY ALINITY M EBV AMP KIT (LIST 09N43-095) LOT 391395 WAS NOT IDENTIFIED

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M EBV ASSAY, LIST NUMBER 09N43-095 WHICH RECEIVED FDA APPROVAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A MISQUANTIFIED LOW RESULT ON THE ALINITY M EBV AMP KIT. SID (SAMPLE ID) (B)(6) WAS TESTED THREE TIMES: FIRST RESULT ( ON (B)(6) 2024): ABOUT 700IU/ML (B)(6) . SECOND RESULT (02/21/2024) : ABOUT 3000IU/ML (B)(6). THIRD RESULT (02/21/2024): ABOUT 3000IU/ML (B)(6). UPON VISUAL INSPECTION OF THE SAMPLE IT WAS HYPOTHESIZED THAT SOME HEMOLYSIS SAMPLE HAD HAPPENED FOR THE FIRST RESULT, AS THE SAMPLE APPEARED TO BE QUITE RED. THE CUSTOMER WAS CONCERNED ABOUT THIS SLIGHT DISCREPANCY. THERE IS NO REPORT OF NEGATIVE IMPACT TO PATIENT MANAGEMENT AND THE THIRD RESULT WAS REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001159 ALINITY M EBV AMP KIT NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV) QLX ABBOTT MOLECULAR, INC. 391395

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown