BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11933013 · Received June 3, 2021

    Report

    Report Number
    1221359-2021-01629
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    March 18, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED TEST KIT LOT 1014263 WITH COVID-19 LOD AND A BLANK PATIENT SWAB ELUTED IN ELUTION BUFFER. ALL TESTS WERE RUN IN DUPLICATE, WERE VALID, AND PERFORMED AS EXPECTED. NO UNEXPECTED OR FALSE POSITIVE RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WERE REVIEWED FOR KIT PART NUMBER 190-000 / LOT 1014263 AND TEST BASE PART NUMBER 190-430 / LOT 1014263. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS WITH NO FALSE POSITIVE RESULTS OBSERVED. THE CURRENT OVERALL PERCENTAGE OF FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING), BASED ON THE TOTAL NUMBER OF DEVICES SOLD AND THE EVIDENCE AVAILABLE, INDICATES THEY ARE PERFORMING AS EXPECTED: LOT 1014263= 0.006% ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED. A REVIEW OF COMPLAINTS AGAINST THE KIT LOTS FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. REPORT : 1221359-2021-01630, 1221359-2021-01631, 1221359-2021-01632. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY, WHICH OCCURRED ON VARIOUS DATES AND ON DIFFERENT LOT NUMBERS. THIS REPORT ADDRESSES LOT ONE (1) OF FOUR (4). THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THE NASAL SAMPLES WERE COLLECTED ON (B)(6) 2021. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING GENERATED NEGATIVE RESULTS. THE NASOPHARYNGEAL SAMPLES IN TRANSPORT MEDIA WERE COLLECTED ON (B)(6) 2021 (ABBOTT M2000 AND (B)(6)). PER THE CUSTOMER ADDITIONAL INFORMATION WILL NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826530 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1014263

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown