BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD KIT 40T EUA

    MDR report key: 16312536 · Received February 7, 2023

    Report

    Report Number
    1221359-2023-00226
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    December 26, 2022
    Report Date
    April 21, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    10811877011290
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 216505 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 216505, TEST BASE PART NUMBER 195-430H / LOT 212841. 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 216505 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 POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES. H3 OTHER TEXT: SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    (DATE OF EVENT): THIS DATE OF EVENT IS AN APPROXIMATION AS THE ACTUAL DATE OF THE TEST WAS NOT PROVIDED BY THE CUSTOMER. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE EVALUATED BY MFR: SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    DUE TO NEW INFORMATION FROM CUSTOMER CONFIRMING FOUR (4) AND NOT FIVE (5) FALSE RESULTS OCCURRED, RELATED MFR. REPORT # 1221359-2023-00230 WILL BE CONSIDERED A NON-REPORTABLE EVENT. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING THAT THERE WERE FOUR (4) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED BETWEEN (B)(6) 2022 AND (B)(6) 2023 AND NOT FIVE (5) AS INITIALLY REPORTED. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2022 USING A NASAL SAMPLE. CONFIRMATION TESTING VIA UNKNOWN PCR WAS PERFORMED USING AN UNKNOWN SWAB TYPE AND GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD FOR MULTIPLE TESTS PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FIVE (5). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON AN UNKNOWN DATE AND USING AN UNKNOWN SWAB TYPE. CONFIRMATION TESTING VIA UNKNOWN PCR WAS PERFORMED USING AN UNKNOWN SWAB TYPE AND GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING THAT THERE WERE FOUR (4) FALSE POSITIVE RESULTS WITH THE BINAXNOW COVID-19 AG CARD PERFORMED BETWEEN (B)(6) 2022 AND (B)(6) 2023 AND NOT FIVE (5) AS INITIALLY REPORTED. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE BINAXNOW COVID-19 AG CARD PERFORMED ON (B)(6) 2022 USING A NASAL SAMPLE. CONFIRMATION TESTING VIA UNKNOWN PCR WAS PERFORMED USING AN UNKNOWN SWAB TYPE AND GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114396 BINAX NOW COVID-19 AG CARD KIT 40T EUA CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 216505 10811877011290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown