BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 SELF-TEST

    MDR report key: 13825764 · Received March 19, 2022

    Report

    Report Number
    1221359-2022-01374
    Event Type
    Malfunction
    Date Received
    March 19, 2022
    Date of Event
    February 23, 2022
    Report Date
    April 27, 2022
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS . A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-01375.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 173258 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 195-160/195-260 / LOT 173258, TEST BASE PART NUMBER 195-430H / LOT 170606. 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 173258 SHOWED THAT THE COMPLAINT RATE IS (B)(4) (02/289800). 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.

    Description of Event or Problem · 0

    HE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 SELF TEST PERFORMED ON (B)(6) 2022 USING A DIRECT TESTED NASAL KITTED SWAB. REPEAT TESTING WAS PERFORMED WITH THE SAME LOT PRODUCING A FALSE POSITIVE RESULT. PCR TEST TAKEN 45 MINUTES LATER PROVIDED NEGATIVE RESULTS. THE PATIENT WAS SYMPTOMATIC, "RUNNY NOSE, HEADACHE, BODY ACHES, FATIGUE. IT WAS THE SECOND DAY OF SYMPTOMS WHEN THE TEST WAS PERFORMED." THE PATIENT HAS SINCE BEEN TESTED TWO OTHER TIMES WITH AN UNKNOWN BRAND OF RAPID ANTIGEN TEST WITH NEGATIVE RESULTS. NO PATIENT TREATMENT PROVIDED DUE TO NEGATIVE PCR RESULT. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF TWO (2) . NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. PER CONSUMER, THE PATIENT WAS SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10648 BINAXNOW COVID-19 SELF-TEST LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC 173258 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female