BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 15940137 · Received December 8, 2022

    Report

    Report Number
    1221359-2022-10257
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 21, 2022
    Report Date
    March 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

    LOT NUMBERS 187352, 209737, AND 208756 WERE PROVIDED BY THE CUSTOMER, BUT NOT ATTRIBUTED TO SPECIFIC DATES OR TESTS. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBERS 187352, 209737, AND 208756 WERE PROVIDED BY THE CUSTOMER, BUT NOT ATTRIBUTED TO SPECIFIC DATES OR TESTS. AS THE CONSUMER WAS UNABLE TO DETERMINE WHICH LOT NUMBERS WERE ATTRIBUTED TO SPECIFIC DATES OR TESTS, THE INVESTIGATION FINDINGS FOR EACH LOT NUMBER UTILIZED ARE LISTED BELOW. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 187352 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 187352, TEST BASE PART NUMBER 195-430H / LOT 183385. 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 187352 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 209737 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 209737, TEST BASE PART NUMBER 195-430WL/LOT 206627. 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 209737 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 208756 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 208756, TEST BASE PART NUMBER 195-430WL/ LOT 205737. 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 208756 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. H3 OTHER TEXT: SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST FOR THREE LOTS AND MULTIPLE TESTS PERFORMED BETWEEN (B)(6) 2022 AND (B)(6) 2022. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FOUR (4). THE CUSTOMER WAS UNABLE TO CONFIRM THE QUANTITY OF FALSE POSITIVE RESULTS THAT OCCURRED WITH EACH LOT. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2022 ON A NASAL SWAB. CONFIRMATION TESTING VIA FLOWFLEX HOME TEST AND AN UNKNOWN PCR AT A DOCTOR'S OFFICE WAS PERFORMED LATER THE SAME DAY AND GENERATED A NEGATIVE RESULT. THE CONSUMER IS REPORTEDLY USING FLUTICASONE NASAL SPRAY; HOWEVER, NO INFORMATION WAS PROVIDED REGARDING SYMPTOMS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF-TEST FOR THREE LOTS AND MULTIPLE TESTS PERFORMED BETWEEN (B)(6) 2022 AND (B)(6) 2022. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF FOUR (4). THE CUSTOMER WAS UNABLE TO CONFIRM THE QUANTITY OF FALSE POSITIVE RESULTS THAT OCCURRED WITH EACH LOT. THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG SELF-TEST PERFORMED ON (B)(6) 2022 ON A NASAL SWAB. CONFIRMATION TESTING VIA FLOWFLEX HOME TEST AND AN UNKNOWN PCR AT A DOCTOR'S OFFICE WAS PERFORMED LATER THE SAME DAY AND GENERATED A NEGATIVE RESULT. THE CONSUMER IS REPORTEDLY USING FLUTICASONE NASAL SPRAY; HOWEVER, NO INFORMATION WAS PROVIDED REGARDING SYMPTOMS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441462 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 74 YR Female