BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 SELF-TEST

    MDR report key: 13090682 · Received December 27, 2021

    Report

    Report Number
    1221359-2021-03857
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    November 20, 2021
    Report Date
    April 14, 2022
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 170185 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 TEST KIT PART NUMBER 195-160 LOT 170185 AND TEST BASE PART NUMBER 195-430H/LOT 168267. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 170185 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE TEST RESULT USING THE BINAXNOW¿ COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK, PERFORMED ON (B)(6) 2021 USING A SWAB SPECIMEN SAMPLE. CONFIRMATION PCR TESTING CONDUCTED THREE DAYS LATER ON (B)(6) 2021 CONCLUDED A POSITIVE COVID-19 TEST RESULT ON A SWAB SPECIMEN SAMPLE FOR THIS PATIENT. THIS PATIENT THEN TOOK AN ADDITIONAL BINAXNOW COVID-19 ANTIGEN SELF TEST ON (B)(6) 2021 AND RECEIVED ANOTHER FALSE NEGATIVE RESULT. THIS MANUFACTURER REPORT ADDRESSES THE ALLEGED TWO FALSE NEGATIVE RESULTS OUT OF TWO TESTS USING THE KIT WITH LOT NUMBER 170185. THE PATIENT WAS CONFIRMED TO BE SYMPTOMATIC; REPORTING A RUNNY NOSE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984710 BINAXNOW COVID-19 SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 170185 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Male