BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 12222549 · Received July 24, 2021

    Report

    Report Number
    1221359-2021-02074
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Report Date
    February 4, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LOT NUMBER. PLEASE SEE UPDATES: D4, G3, G6, H2 AND H6.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 131414 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 195-000 / LOT 131414 AND TEST BASE PART NUMBER 195-430H / LOT 129337A. 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 131414 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW (BRR) REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE, AND REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES THAT THE PRODUCT IS PERFORMING ACCORDING TO THE STATEMENTS CONTAINED IN THE PACKAGE INSERT AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CROSS SECTIONAL STUDY ASSESSING THE PERFORMANCE OF RAPID SARS-COV-2 ANTIGEN DETECTION ASSAYS IN SYMPTOMATIC CHILDREN, FALSE POSITIVE RESULTS OCCURRED WITH THE BINAXNOW COVID-19 AG CARD ASSAY IN (B)(6) 2020. THE CUSTOMER STATED THAT TWO NASAL (MIDDLE TURBINATE) SWABS WERE OBTAINED FROM EACH PATIENT, AND USED TO SWAB BOTH NOSTRILS. THE CUSTOMER REPORTED THAT ONE SWAB WAS USED FOR AN IN-OFFICE BINAXNOW COVID-19 AG CARD AND THERE WAS ONE TRAINED READER TO VISUALLY INTERPRET THE TEST CARDS (ANY VISIBLE BAND WAS CONSIDERED POSITIVE). THE SECOND SPECIMEN WAS PLACED IN TRANSPORT MEDIA AND SUBMITTED FOR QUALITATIVE REAL-TIME POLYMERASE CHAIN REACTION (RT- PCR) FOR SARS-COV-2 RNA USING THE ROCHE COBAS OR HOLOGIC PANTHER PLATFORMS AT A LOCAL CLINICAL LABORATORY. AS PART OF THE PROTOCOL FOR THE STUDY CHILDREN WERE TESTED WITH SYMPTOMS FOR <7 DAYS PRESENTING WITH ONE OF THE FOLLOWING: COUGH, SHORTNESS OF BREATH, DIFFICULTY BREATHING, LOSS OF SMELL OR TASTE, SEVERE RESPIRATORY ILLNESS; OR TWO OF THE FOLLOWING: KNOWN EXPOSURE TO COVID-19, FEVER OR CHILLS, CONGESTION OR RUNNY NOSE, BODY ACHES, FATIGUE, HEADACHE, SORE THROAT, NAUSEA, VOMITING, OR DIARRHEA. A TOTAL OF 199 CHILDREN AGED 2 MONTHS TO 20 YEARS WERE INCLUDED; 39 HAD POSITIVE PCR FOR SARS COV-2. THE CUSTOMER REPORTED THAT THE SPECIFICITIES WERE OBSERVED TO BE LOWER THAN EXPECTED IN THIS GROUP OF PATIENTS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119615 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 131414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown