BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15806495 · Received November 16, 2022

    Report

    Report Number
    1221359-2022-10148
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    November 9, 2022
    Report Date
    January 25, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 211283 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 195-160 / LOT 211283 AND DEVICE PART NUMBER 195-430H / LOT 207629. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO FALSE NEGATIVE RESULTS OBSERVED. THE REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE RESULTS (CONFIRMED, UNCONFIRMED AND CONFLICTING RESULTS) RELATED TO KIT LOT 211283 SHOWED THAT THE COMPLAINT RATE IS(B)(4). A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 ANTIGEN SELF TEST ASSAY PERFORMED ON (B)(6)2022 ON A NASAL KITTED SWAB. THE CONSUMER CONFIRMED THAT SHE HAD COVID-19 A WEEK AGO AND REPORTEDLY SHE IS STILL NOT FEELING WELL. THE CONSUMER STATED THAT SHE WAS GIVEN A COUGH MEDICINE. THE CONSUMER CONFIRMED THAT SHE IS FOLLOWING UP WITH HER HEALTHCARE PROVIDER BECAUSE OF A FALSE NEGATIVE RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 ANTIGEN SELF TEST ASSAY PERFORMED ON (B)(6) 2022 ON A NASAL KITTED SWAB. THE CONSUMER CONFIRMED THAT SHE HAD COVID-19 A WEEK AGO AND REPORTEDLY SHE IS STILL NOT FEELING WELL. THE CONSUMER STATED THAT SHE WAS GIVEN A COUGH MEDICINE. THE CONSUMER CONFIRMED THAT SHE IS FOLLOWING UP WITH HER HEALTHCARE PROVIDER BECAUSE OF A FALSE NEGATIVE RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351974 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211283 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female