BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT

    MDR report key: 12937580 · Received December 6, 2021

    Report

    Report Number
    3005248192-2021-00444
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 17, 2021
    Report Date
    February 11, 2022
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ELEVATED COMPLAINT INVESTIGATION WILL BE INITIATED. NOTE: LOT, EXPIRATION, UDI, MANUFACTURE DATE AND PMA NUMBER HAVE BEEN LEFT BLANK AS THIS MDR IS BEING SUBMITTED ON THE BASIS THAT ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT (LIST 9N78-90) IS SIMILAR TO THE ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT (LIST 9N78-95) SOLD IN THE UNITED STATES. TICKET DOES NOT REFERENCE A US LIST 9N78-95 LOT NUMBER.

    Additional Manufacturer Narrative · 0

    B5 UPDATED TO INDICATE THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN GERMANY, NOT FRANCE. INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW AND A COMPLAINT HISTORY REVIEW. INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW CUSTOMER RESULT LOG FILES WERE REVIEWED. THE RUNS INVOLVING SAMPLE IDENTIFICATION (SID) LISTED IN THE TICKET WERE VALID, MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE CONTROLS. THERE IS NO POTENTIAL AMP PLATE CARRYOVER RISK FOR ANY SIDS IN THIS INVESTIGATION AFTER REVIEWING THE PLATE MAPPING ANALYSIS. THE REVIEW OF THE CUSTOMER DATA DEMONSTRATED THAT THE ASSAY SOFTWARE AND THE ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-090) LOT 519784 AND 520388 ARE PERFORMING AS EXPECTED. THE ASSAY REAGENTS PERFORMED AS EXPECTED AND MET THE ASSAY SPECIFICATION REQUIREMENTS FOR THE CONTROLS. THERE IS NO INDICATION THAT LOT 519784 AND 520388 ARE PERFORMING OUTSIDE OF ESTABLISHED DESIGN PERFORMANCE SPECIFICATIONS. QUALITY DATA REVIEW DEVICE HISTORY RECORD (DHR) / BATCH RECORD REVIEW: REVIEW OF THE MANUFACTURING PACKETS FOR ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-090) LOT 520388 AND 519784 DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED COMPLAINT. NO RECORDS RELATED TO THE REPORTED COMPLAINT WERE FOUND AND DID NOT IDENTIFY ANY ISSUES WHICH COULD HAVE LED TO THE REPORTED COMPLAINT. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. THE AMP KIT MASTERLOT TESTING MET ALL ACCEPTANCE AND VALIDITY SPECIFICATION CRITERIA. CAPA / NON-CONFORMANCE REVIEW: A CAPA REVIEW WAS PERFORMED TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT FOR ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-090) LOTS 520388 AND 519784 AND THEIR COMPONENTS. THIS CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL ISSUES OR NONCONFORMANCES RELATED TO THE REPORTED COMPLAINT FOR LOTS 520388 AND LOT 519784, AND THEIR COMPONENTS. COMPLAINT HISTORY REVIEW A 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 09N78-090) LOTS 520388 AND 519784. COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY ADDITIONAL COMPLAINT TICKETS RELATED TO THE REPORTED ISSUE FOR ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-090) LOTS 520388 AND 519784. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-090) LOTS 520388 AND 519784 WERE NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT 2 SARS-COV-2 POSITIVE RESULTS RETRIEVED ON THEIR ALINITY M COULD NOT BE VERIFIED ON A COMPETITOR INSTRUMENT (CEPHEID GENEXPERT). THE CUSTOMER STATED THAT THE SAMPLE HAD A CYCLE COUNT (CT) VALUE OF 37.66 ON ALINITY M SARS-COV-2 ASSAY (LOT NUMBER 520388) BUT WAS NEGATIVE ON CEPHEID GENEXPERT. THE SAMPLE WAS PROCESSED ON SEPTEMBER 13, 2021. AMP KIT MAPPING ANALYSIS DID NOT SHOW ANY CROSS OVER CONTAMINATION ON THE AMP TRAY. THE CUSTOMER REPORTED THAT THE SECOND SAMPLE HAD A CT OF 35.03 ON ALINITY M SARS-COV-2 ASSAY (LOT NUMBER 519784) BUT WAS NEGATIVE ON CEPHEID GENEXPERT FOR THE E GENE, BUT HAD A CT VALUE FOR THE N GENE AT 39.1 ON CEPHEID GENEXPERT. A NEW SWAB WAS TAKEN THE NEXT DAY FROM THE PATIENT. THE SINGLE SAMPLES (NOT THE POOLED SAMPLES) WERE THE ONES RETESTED ON THE CEPHEID GENEXPERT. WHEREAS THE POOLED SAMPLES WERE THE ONES THAT RESULTED POSITIVE ON THE ALINITY M. ALLL SINGLE SAMPLES RESULTED NEGATIVE. THE LOCAL AMBASSADOR INFORMED THE CUSTOMER THE DIFFERENCES BETWEEN THE TWO INSTRUMENTS WHICH HAVE BEEN USED FOR TESTING (E.G. DIFFERENT GENE DETECTION AND LIMIT OF DETECTION). THAT THE ALINITY M SARS-COV-2 ASSAY NOT ONLY DETECTS THE N GEN (AS THE CEPHEID GENEXPERT) BUT THE ORF1 REGION AS WELL WHICH CAN LEAD TO DIFFERENT RESULTS BETWEEN THE TWO SYSTEMS. IT WAS CONFIRMED ONLY THE NEGATIVE RESULTS WERE REPORTED OUTSIDE THE LAB THAT WERE RETRIEVED ON CEPHEID GENEXPERT.THEREFORE, THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENT MANAGEMENT DUE TO THIS OBSERVATION. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN FRANCE USING THE ALINITY M SARS-COV-2 ASSAY, LIST NUMBER 9N78-90, WHICH IS THE SAME/ SIMILAR TO THE ALINITY M SARS-COV-2 ASSAY, LIST NUMBER 9N78-95, WHICH RECEIVED FDA EUA APPROVAL.

    Description of Event or Problem · 0

    THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN GERMANY USING THE ALINITY M SARS-COV-2 ASSAY, LIST NUMBER 9N78-90, WHICH IS THE SAME/ SIMILAR TO THE ALINITY M SARS-COV-2 ASSAY, LIST NUMBER 9N78-95, WHICH RECEIVED FDA EUA APPROVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838733 ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 9N78-95

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown