BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17631073 · Received August 28, 2023

    Report

    Report Number
    1221359-2023-01370
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 15, 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

    D4: THE CUSTOMER WAS NOT ABLE TO CONFIRM WHICH LOT WAS INVOLVED WITH THIS EVENT, BUT PROVIDED THE POSSIBLE LOTS BELOW: LOT: M219370; EXPIRATION DATE: 29OCT2023; MANUFACTURE DATE: 01OCT2022. LOT: 1096698; EXPIRATION DATE: 02DEC2023; MANUFACTURE DATE: 05NOV2022. G4: SIMILAR PRODUCT TO 192-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M219370 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 KIT PART NUMBER 193-000 / LOT M219370 AND TEST BASE PART NUMBER 192-430 / LOT M219370. 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 M219370 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOGFILES WERE NOT PROVIDED BY THE CUSTOMER. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1096698 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 KIT PART NUMBER 193-000 / LOT 1096698 AND TEST BASE PART NUMBER 192-430 / LOT 1096698. 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 1096698 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOGFILES WERE NOT PROVIDED BY THE CUSTOMER. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    THE CONSUMER IS UNSURE WHICH OF TWO LOT NUMBERS WAS USED: D4: LOT NUMBER: 218685, UDI: (B)(4), EXP. DATE: 6/7/2024. LOT NUMBER: 219428, UDI: (B)(4), EXP. DATE: 7/10/2024. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER STATED THAT THEY ARE NOT SURE WHICH OF THE TWO LOT NUMBERS WAS USED TO COLLECT THE NASAL SAMPLE. THE CONSUMER STATED THE PATIENT WAS EXPOSED TO SOMEONE WITH COVID-19 AND IS ON DAY TWO OF HAVING SYMPTOMS (DRY COUGH, FEVER, AND BODY CHILLS) ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 AG SELF TEST FOR TWO TESTS PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER STATED THAT THEY ARE NOT SURE WHICH OF THE TWO LOT NUMBERS WAS USED TO COLLECT THE NASAL SAMPLE. THE CONSUMER STATED THE PATIENT WAS EXPOSED TO SOMEONE WITH COVID-19 AND IS ON DAY TWO OF HAVING SYMPTOMS (DRY COUGH, FEVER, AND BODY CHILLS) ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435024 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 219428 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female