BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT

    MDR report key: 16249157 · Received January 26, 2023

    Report

    Report Number
    3005248192-2023-00079
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    August 30, 2022
    Report Date
    January 26, 2023
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. THE INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW: CUSTOMER RESULT LOG FILES WERE REVIEWED. THE RUN WHICH INVOLVED THE DISCREPANT RESULT WAS VALID AND MET ASSAY SPECIFICATION REQUIREMENTS. THE VALIDITY OF THE RUN MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE RUN CONTROLS. NO ABNORMAL AMPLIFICATION CURVES WERE IDENTIFIED, AND THE ASSAY IS PERFORMING AS EXPECTED WITH CORRECT INTERPRETATIONS. DIFFERENT PLATFORMS HAVE DIFFERENT LIMITS OF DETECTION (LOD) THEREFORE, THE RESULTS MAY NOT BE REPRODUCIBLE. THERE IS NO INDICATION THAT ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOTS 526394, 526395, AND 526485 IS PERFORMING OUTSIDE OF ESTABLISHED DESIGN PERFORMANCE SPECIFICATIONS BASED ON THE ELEMENTS REVIEWED IN THIS SECTION. QUALITY DATA REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOTS 526394, 526395, AND 526485 (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. THE PRODUCTS PASSED QUALITY SPECIFICATIONS AT THE TIME OF RELEASE. CAPA / NON-CONFORMANCE REVIEW: THE CAPA REVIEW FOR ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOTS 526394, 526395, AND 526485 (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 LOT NUMBERS. COMPLAINT HISTORY REVIEW: A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKET BEING INVESTIGATED, WHICH REPORTED DISCREPANT RESULTS WHILE USING ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOTS 526394, 526395, AND 526485. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOTS 526394, 526395, AND 526485 WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SIDS (SAMPLE IDS) (B)(6) WERE RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING EVENT OF PATIENTS AND EMPLOYEES. ON 01/23/2023 IT WAS IDENTIFIED THAT ADDITIONAL REPORTS WERE REQUIRED TO BE SUBMITTED AS PART OF THIS EVENT. THIS REPORT IS BEING SUBMITTED WITH THE FOLLOWING MDRS: 3005248192-2022-01050; 3005248192-2022-01051; 3005248192-2022-01052; 3005248192-2023-00050; 3005248192-2023-00051; 3005248192-2023-00052; 3005248192-2023-00053; 3005248192-2023-00054; 3005248192-2023-00055; 3005248192-2023-00056; 3005248192-2023-00057; 3005248192-2023-00058; 3005248192-2023-00059; 3005248192-2023-00060; 3005248192-2023-00061; 3005248192-2023-00062; 3005248192-2023-00063; 3005248192-2023-00064; 3005248192-2023-00065; 3005248192-2023-00066; 3005248192-2023-00067; 3005248192-2023-00068; 3005248192-2023-00069; 3005248192-2023-00070; 3005248192-2023-00071; 3005248192-2023-00072; 3005248192-2023-00073; 3005248192-2023-00074; 3005248192-2023-00075; 3005248192-2023-00076; 3005248192-2023-00077; 3005248192-2023-00078; 3005248192-2023-00080; 3005248192-2023-00081.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793834 ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 09N78-095 526485 00884999049222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown