BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16188025 · Received January 17, 2023

    Report

    Report Number
    1221359-2023-00112
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    December 26, 2022
    Report Date
    February 3, 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 SECOND LOT USED DURING THIS EVENT: 212342; EXPIRATION DATE: 01OCT2023; UDI: (B)(4). 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 AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOTS 210729 AND 212432 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 210729, TEST BASE PART NUMBER 195-430H/ LOT 207118 AND TEST KIT PART NUMBER 195-160 /LOT 212342, TEST BASE PART NUMBER 195-430WJR /LOT 209880. THE LOTS MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 210729 AND KIT LOT 212342 SHOWED THAT THE COMPLAINT RATE IS (B)(4). RESPECTIVELY. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 210729 AND KIT LOT 212342 SHOWED THAT THE COMPLAINT RATE IS (B)(4). RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.D4: AS THIS IS A CASE OF CONFLICTING RESULT, IT IS NOT DETERMINED WHICH LOT IS THE SUSPECT PRODUCT. THE LOT NUMBERS THAT WERE INVOLVED IN THIS EVENT ARE AS FOLLOWS: LOT: 210729; EXPIRATION DATE: 14SEP2023; UDI: 00811877011408 AND LOT: 212342; EXPIRATION DATE: 01OCT2023; UDI:00811877011408 H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS BETWEEN TWO (2) BINAXNOW COVID-19 ANTIGEN SELF-TESTS, BOTH PERFORMED ON (B)(6) 2022 ON A NASAL SWAB. THE FIRST TEST WAS COMPLETED BY THE CONSUMER IN THEIR HOME AND GENERATED A POSITIVE RESULT. THE SECOND TEST WAS PERFORMED WITH A DIFFERENT LOT BY THE CONSUMER WITH INSTRUCTION FROM ABBOTT TECHNICAL SERVICE VIA THE PHONE AND GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER PERFORMED TWO (2) ADDITIONAL BINAXNOW COVID-19 SELF-TESTS THE FOLLOWING DAY ((B)(6) 2022), BOTH OF WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS BETWEEN TWO (2) BINAXNOW COVID-19 ANTIGEN SELF-TESTS, BOTH PERFORMED ON (B)(6)2022 ON A NASAL SWAB. THE FIRST TEST WAS COMPLETED BY THE CONSUMER IN THEIR HOME AND GENERATED A POSITIVE RESULT. THE SECOND TEST WAS PERFORMED WITH A DIFFERENT LOT BY THE CONSUMER WITH INSTRUCTION FROM ABBOTT TECHNICAL SERVICE VIA THE PHONE AND GENERATED A NEGATIVE RESULT. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER PERFORMED TWO (2) ADDITIONAL BINAXNOW COVID-19 SELF-TESTS THE FOLLOWING DAY (27DEC2022), BOTH OF WHICH GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81072 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. UNKNOWN 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown