BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16176137 · Received January 16, 2023

    Report

    Report Number
    1221359-2023-00103
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    January 10, 2023
    Report Date
    April 5, 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

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 215068 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 215068 AND DEVICE PART NUMBER 195-430WJR/LOT 212838. 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 215068 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT: SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED SIX (6) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST FOR ONE PATIENT AND MULTIPLE TESTS PERFORMED BETWEEN (B)(6) 2022 AND (B)(6) 2023. THIS MFR. REPORT ADDRESSES TEST SIX (6) OF SIX (6). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON (B)(6) 2023 ON A NASAL SWAB. CONFIRMATION TESTING VIA UNKNOWN PCR AT A CVS PHARMACY WAS PERFORMED THREE (3) DAYS PRIOR (B)(6) 2023) ON AN UNKNOWN SWAB AND GENERATED A NEGATIVE RESULT (THAT THE CONSUMER RECEIVED ON (B)(6) 2023). THE CONSUMER STATED THAT HE WAS SYMPTOMATIC BEGINNING ON (B)(6) 2022. HE NOTED THAT HE HAD A "RUNNY NOSE, COUGH, MUCUS DISCHARGE, AND COLD CHILLS". THE CONSUMER REPORTED THAT HE WAS PRESCRIBED PAXLOVID TABLETS TO TAKE FOR FIVE (5) DAYS AND TO QUARANTINE FOR ELEVEN (11) DAYS, BEGINNING ON (B)(6) 2022. ADDITIONALLY, THE PATIENT STATED THAT HE EMAILED HIS DOCTOR THE CVS PHARMACY NEGATIVE PCR RESULT ON (B)(6) 2023 AND WAS INFORMED THAT HE COULD STOP QUARANTINING.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED SIX (6) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST FOR ONE PATIENT AND MULTIPLE TESTS PERFORMED BETWEEN 31DEC2022 AND 10JAN2023. THIS MFR. REPORT ADDRESSES TEST SIX (6) OF SIX (6). THE CONSUMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 ANTIGEN SELF-TEST PERFORMED ON 10JAN2023 ON A NASAL SWAB. CONFIRMATION TESTING VIA UNKNOWN PCR AT A CVS PHARMACY WAS PERFORMED THREE (3) DAYS PRIOR (07JAN203) ON AN UNKNOWN SWAB AND GENERATED A NEGATIVE RESULT (THAT THE CONSUMER RECEIVED ON 09JAN2023). THE CONSUMER STATED THAT HE WAS SYMPTOMATIC BEGINNING ON 28DEC2022. HE NOTED THAT HE HAD A "RUNNY NOSE, COUGH, MUCUS DISCHARGE, AND COLD CHILLS". THE CONSUMER REPORTED THAT HE WAS PRESCRIBED PAXLOVID TABLETS TO TAKE FOR FIVE (5) DAYS AND TO QUARANTINE FOR ELEVEN (11) DAYS, BEGINNING ON 31DEC2022. ADDITIONALLY, THE PATIENT STATED THAT HE EMAILED HIS DOCTOR THE CVS PHARMACY NEGATIVE PCR RESULT ON 12JAN2023 AND WAS INFORMED THAT HE COULD STOP QUARANTINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359598 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 215068 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male