BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16038069 · Received December 22, 2022

    Report

    Report Number
    1221359-2022-10385
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 19, 2022
    Report Date
    February 21, 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 213657 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 195-160 / LOT 213657 AND DEVICE PART NUMBER 195-430WL / LOT 212051. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO CONFLICTING RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR LOT 213657 BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS 0.00103%. BASED ON THE EVIDENCE AVAILABLE, THE LOT IS PERFORMING AS EXPECTED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR LOT 213657 BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS 0.000686%. BASED ON THE EVIDENCE AVAILABLE, THE LOT IS PERFORMING AS EXPECTED. NO ADDITIONAL INVESTIGATION IS NECESSARY AS A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED COMPLETE. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A CONFLICTING RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON 19DEC2022 ON NASAL SWAB. THE CONSUMER MAY NOT FOLLOW THE LABEL INSTRUCTIONS, SO SHE ADDED MORE THAN 6 DROPS INTO THE TOP HOLE OF THE TEST CARD, AND SHE GOT A POSITIVE RESULT ON (B)(6) 2022. ALSO, THE CONSUMER SUSPECTED THE RESULT OF THE FIRST TEST, SO SHE TOOK OTHER TWO BINAXNOW COVID-19 AG SELF-TEST TESTS ON (B)(6) 2022 AND SHE GOT NEGATIVE RESULTS ON THEM. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED A CONFLICTING RESULT WITH BINAXNOW COVID-19 AG SELF-TEST ON (B)(6)2022 ON NASAL SWAB. THE CONSUMER MAY NOT FOLLOW THE LABEL INSTRUCTIONS, SO SHE ADDED MORE THAN 6 DROPS INTO THE TOP HOLE OF THE TEST CARD, AND SHE GOT A POSITIVE RESULT ON (B)(6) 2022. ALSO, THE CONSUMER SUSPECTED THE RESULT OF THE FIRST TEST, SO SHE TOOK OTHER TWO BINAXNOW COVID-19 AG SELF-TEST TESTS ON (B)(6) 2022, AND SHE GOT NEGATIVE RESULTS ON THEM. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613116 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 213657 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female