BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16009685 · Received December 19, 2022

    Report

    Report Number
    1221359-2022-10361
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    December 5, 2022
    Report Date
    February 10, 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 AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT: 212593 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: 212593, TEST BASE PART NUMBER: 195-430H/ LOT: 206900. THE LOT 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: 212593 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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. A1: PATIENT IDENTIFIER CORRECTED TO (B)(6). B5: ADDITIONAL PHRASE ADDED: "THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2)." D4: EXPIRATION DATE CHANGED TO 4/28/2024 DUE TO EXPIRATION DATE EXTENSION. H3 OTHER TEXT: SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022 ON A NASAL SAMPLE. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER HAD PRIOR TESTING PERFORMED AT THE HOSPITAL VIA AN UNKNOWN METHOD WHICH GENERATED A NEGATIVE RESULT ON (B)(6) 2022. THE CONSUMER WAS SYMPTOMATIC ON 2DEC2022 BUT ASYMPTOMATIC AS OF (B)(6) 2022. THE CONSUMER CONFIRMED THERE WAS NO DELAY IN TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2022 ON A NASAL SAMPLE. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING WAS NOT PERFORMED. THE CONSUMER HAD PRIOR TESTING PERFORMED AT THE HOSPITAL VIA AN UNKNOWN METHOD WHICH GENERATED A NEGATIVE RESULT ON (B)(6) 2022. THE CONSUMER WAS SYMPTOMATIC ON (B)(6) 2022 BUT ASYMPTOMATIC AS OF ON (B)(6) 2022. THE CONSUMER CONFIRMED THERE WAS NO DELAY IN TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151925 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 212593 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male