BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT

    MDR report key: 10741120 · Received October 27, 2020

    Report

    Report Number
    3005248192-2020-00090
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    April 21, 2020
    Report Date
    February 9, 2022
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049109
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW. THE RESULTS OF THE INVESTIGATION ARE SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW: THE CUSTOMER RUN DATA WAS VALID, MET ASSAY SPECIFICATION REQUIREMENTS, AND NO ERROR CODES OR FLAGS WERE DISPLAYED FOR THE CONTROLS. QUALITY DATA REVIEW: THE DEVICE HISTORY RECORDS (DHR) REVIEW FOR ABBOTT REALTIME SARS-COV-2 AMP RGT KIT (LIST 09N77-95) LOT 504783 AND ITS COMPONENTS WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY ISSUES WHICH COULD RESULT IN THE REPORTED EVENT DURING THE PRODUCTION OR THE RELEASE TESTING FOR LOT 504783. THE CAPA REVIEW FOR ABBOTT REALTIME SARS-COV-2 AMP RGT KIT (LIST 09N77-95) LOT 504783 AND ITS COMPONENTS WAS PERFORMED AND DID NOT IDENTIFY ANY INTERNAL OR POST-PRODUCTION USE ISSUES RELATED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW: THE LOT SPECIFIC COMPLAINT HISTORY REVIEW FOR ABBOTT REALTIME SARS-COV-2 AMP RGT KIT (LIST 09N77-95) LOT 504783 IDENTIFIED THREE (3) ADDITIONAL COMPLAINTS RELATED TO THE REPORTED ISSUE. ALL WERE INDEPENDENTLY INVESTIGATED UNDER AND NO PRODUCT DEFICIENCIES WERE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR THE ABBOTT REALTIME SARS-COV-2 AMP RGT KIT (LIST 09N77-95) LOT 504783 WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    COMPLAINT INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, FOR A PATIENT NO LONGER EXHIBITING SYMPTOMS, A CLINICIAN QUESTIONED A POSITIVE RESULT GENERATED ON THE REALTIME SARS COV-2 ASSAY. CUSTOMER REPORTED THE CLINICIAN QUESTIONED THE POSITIVE RESULT AND THE SAMPLE WAS RETESTED ON ANOTHER PLATFORM USING A LABORATORY DEVELOPED TEST (LDT) ASSAY. THE LDT ASSAY RESULT WAS NEGATIVE. SAMPLE WAS RECOLLECTED FROM THE PATIENT AND TESTED ON THE REALTIME SARS-COV-2 ASSAY. RECOLLECTED SAMPLE WAS NEGATIVE. ORIGINAL RESULT WAS AMENDED AND REPORTED AS A FALSE POSITIVE. PATIENT MANAGEMENT WAS NOT IMPACTED AND PATIENT WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207075 ABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 09N77-095 504783 00884999049109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown