BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 17435945 · Received August 1, 2023

    Report

    Report Number
    1221359-2023-01306
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 1, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 219026 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 195-160/ LOT 219026 AND DEVICE PART NUMBER 195-430H/ LOT 213046. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 219026 SHOWED THAT THE COMPLAINT RATE IS 0.000684%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THAT HER1221359-2023-01302 MOTHER HAD EXPERIENCED TWO (2) FALSE NEG(B)(6)2023. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2). THE CONSUMER REPORTED THAT HER MOTHER RECEIVED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. CONFIRMATION TESTING VIA UNKNOWN TESTING PLATFORM WAS PERFORMED AT A HOSPITAL TWO (2) DAYS LATER ((B)(6) 2023) USING A NASAL SAMPLE AND GENERATED A POSITIVE RESULT. THE CONSUMER DID NOT REPORT ANY SYMPTOMS ATTRIBUTED SPECIFICALLY TO COVID-19 AT THE TIME OF TESTING BUT MENTIONED THAT HER MOTHER HAS ASTHMA AND WAS TAKING TREATMENT FOR THIS PRE-EXISTING CONDITION. THE CONSUMER CONFIRMED THAT HER MOTHER DID NOT REQUIRE ANY MEDICAL ATTENTION BUT NOTED THAT SHE WOULD BE HAVING AN UPDATE WITH HER DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342318 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 219026 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 Female