BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT

    MDR report key: 12860691 · Received November 23, 2021

    Report

    Report Number
    3005248192-2021-00386
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 26, 2021
    Report Date
    March 31, 2022
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049222
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER WAS IDENTIFIED, SO HAS BEEN UPDATED IN THIS REPORT. ADDITIONALLY, THE CORRESPONDING EXPIRATION DATE AND DATE OF MANUFACTURE HAVE BEEN INCLUDED. 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: NO ACTUAL DISCREPANT RESULTS WERE IDENTIFIED AFTER REVIEWING THE REPORTED SAMPLE IDS (SIDS) FROM THE TICKET. ALL THREE SIDS FROM THE SAME PATIENT GENERATED A POSITIVE RESULT IN THREE SEPARATE TEST RUNS. THERE IS NO FALSE POSITIVE DISCREPANT RESULT WHEN THERE IS NO NEGATIVE RESULT IDENTIFIED. THERE IS NO INDICATION THAT THE SOFTWARE AND LOT 522133 ARE NOT PERFORMING AS EXPECTED AS THERE WERE NO TRUE FALSE POSITIVES RESULTS REPORTED. QUALITY DATA REVIEW: DEVICE HISTORY RECORD (DHR) / BATCH RECORD REVIEW: REVIEW OF THE MANUFACTURING PACKET FOR ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOT 522133 DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED COMPLAINT. NO ISSUES WERE FOUND DURING QUALITY CONTROL (QC) TESTING. THE AMPLIFICATION KIT MASTERLOT TESTING MET ALL ACCEPTANCE AND VALIDITY SPECIFICATION CRITERIA. CAPA / NON-CONFORMANCE REVIEW: A CAPA REVIEW WAS PERFORMED IN TO IDENTIFY ANY RECORDS THAT WERE POTENTIALLY RELATED TO THE REPORTED COMPLAINT FOR ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) 522133 AND ITS COMPONENTS. THIS CAPA REVIEW DID NOT IDENTIFY ANY EXISTING INTERNAL ISSUES OR NONCONFORMANCES THAT ARE RELATED TO THE REPORTED COMPLAINT. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE TICKETS BEING INVESTIGATED, WHICH REPORTED DISCREPANT RESULTS WHILE USING ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOT 522133. THE COMPLAINT HISTORY REVIEW IDENTIFIED 7 ADDITIONAL COMPLAINTS RELATED TO THE REPORTED ISSUE FOR THE ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOT 522133. 1 TICKET WAS INDEPENDENTLY INVESTIGATED, AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE OTHER 6 TICKETS ARE CURRENTLY BEING INDEPENDENTLY INVESTIGATED. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOT 522133 WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ELEVATED COMPLAINT INVESTIGATION WILL BE CONDUCTED. SINCE THE LOT NUMBER IS UNKNOWN, THE MANUFACTURING AND EXPIRATION DATES HAVE BEEN LEFT BLANK.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A FALSE POSITIVE RESULT ON THE ALINITY M SARS COV-2 ASSAY. A PATIENT INITIALLY TESTED POSITIVE TWICE ON THE ALINITY M SARS-COV-2 ASSAY. THE PATIENT IS ASYMPTOMATIC AND CALLED TO HAVE THEIR RESULTS CHECKED. THERE WAS NO REPORT OF ANY IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758178 ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 09N78-095 522133 00884999049222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown