BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15890279 · Received November 30, 2022

    Report

    Report Number
    1221359-2022-10209
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 10, 2022
    Report Date
    January 31, 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

    TESTING WAS PERFORMED IN TRIPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 180939 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 180939 AND DEVICE PART NUMBER 195-430H / LOT 173383. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS. THE REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED, UNCONFIRMED AND CONFLICTING RESULTS) RELATED TO KIT LOT 180939 SHOWED THAT THE COMPLAINT RATE IS(B)(4).. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. 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 TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ASSAY PERFORMED ON (B)(6)2022. THIS MFR. REPORT ADDRESSES RESULT TWO (2) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ASSAY PERFORMED ON (B)(6)2022 ON A NASAL KITTED SWAB. CONFIRMATION TESTING VIA PCR (PLATFORM: UNKNOWN) WAS PERFORMED AT A PHYSICIAN'S OFFICE ON (B)(6)2022 AND GENERATED A POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULT. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENTS TREATMENT. THE CONSUMER STATED SHE IS FINE NOW AND WAS ADVISED TO STAY ISOLATED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ASSAY PERFORMED ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES RESULT TWO (2) OF TWO (2). THE CONSUMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST ASSAY PERFORMED ON (B)(6) 2022 ON A NASAL KITTED SWAB. CONFIRMATION TESTING VIA PCR (PLATFORM: UNKNOWN) WAS PERFORMED AT A PHYSICIAN'S OFFICE ON (B)(6) 2022 AND GENERATED A POSITIVE RESULT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULT. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENTS TREATMENT. THE CONSUMER STATED SHE IS FINE NOW AND WAS ADVISED TO STAY ISOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769536 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 180939 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female