BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15801770 · Received November 15, 2022

    Report

    Report Number
    1221359-2022-10147
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    November 5, 2022
    Report Date
    January 30, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 211607 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 211607 AND TEST DEVICE 195-430WL / LOT 207665. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO FALSE NEGATIVE RESULTS OBSERVED. THE REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED AND CONFLICTING RESULTS) RELATED TO KIT LOT 211607 SHOWED THAT THE COMPLAINT RATE IS(B)(4).. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TEN (10) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED FOR PAST 10 DAYS. THIS MFR. REPORT ADDRESSES RESULT TEN (10) OF THE TEN (10) AND LOT NUMBER 211607 (TOTAL QUANTITY 1). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED NASAL KITTED SWAB. CONFIRMATION TESTING WAS PERFORMED ON (B)(6) 2022 USING OTHER BRAND KIT (BRAND NAME UNKNOWN) GENERATED POSITIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TEN (10) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED FOR PAST 10 DAYS. THIS MFR. REPORT ADDRESSES RESULT TEN (10) OF THE TEN (10) AND LOT NUMBER 211607 (TOTAL QUANTITY 1). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6)2022 ON A DIRECT TESTED NASAL KITTED SWAB. CONFIRMATION TESTING WAS PERFORMED ON (B)(6)2022 USING OTHER BRAND KIT (BRAND NAME UNKNOWN) GENERATED POSITIVE RESULT. THE CONSUMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CONSUMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2786611 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 211607 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male