BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16773211 · Received April 19, 2023

    Report

    Report Number
    1221359-2023-00647
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    April 9, 2023
    Report Date
    May 26, 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 REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D4 - LOT NUMBER: CUSTOMER WAS UNSURE OF EXACT LOT NUMBER, THERE IS A POSSIBILITY THAT IT WAS LOT 223040. LOT INFORMATION BELOW: D4 - EXPIRATION DATE: 14AUG2023. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST. THE CONSUMER STATED THE TEST WAS PERFORMED SEVERAL DAYS PRIOR TO (B)(6) 2023. REPEAT TESTING WAS PERFORMED WHICH GENERATED A POSITIVE RESULT. ADDITIONAL TESTING WAS PERFORMED VIA IHEALTH COVID-19 ANTIGEN RAPID TEST, WHICH GENERATED A POSITIVE RESULT. BOTH OF THESE TESTS WERE PERFORMED ON (B)(6) 2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED AN UNCONFIRMED FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST. THE CONSUMER STATED THE TEST WAS PERFORMED SEVERAL DAYS PRIOR TO(B)(6), 2023. REPEAT TESTING WAS PERFORMED WHICH GENERATED A POSITIVE RESULT. ADDITIONAL TESTING WAS PERFORMED VIA IHEALTH COVID-19 ANTIGEN RAPID TEST, WHICH GENERATED A POSITIVE RESULT. BOTH OF THESE TESTS WERE PERFORMED ON (B)(6), 2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520431 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male