BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW G6PD TEST

    MDR report key: 10228701 · Received July 3, 2020

    Report

    Report Number
    1221359-2020-00125
    Event Type
    Injury
    Date Received
    July 3, 2020
    Date of Event
    May 29, 2020
    Report Date
    January 13, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    JBF
    UDI-DI
    10811877010705
    PMA / PMN Number
    K161364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: RETAIN TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WITH THREE REPLICATES OF PRESUMED NORMAL WHOLE BLOOD AND THREE REPLICATES OF DEFICIENT CONTROL 20U/DL FOR BOTH HEPARIN AND EDTA SAMPLE TYPES. ALL TESTING PERFORMED AS EXPECTED WITH NO OBSERVATIONS OF FALSE NEGATIVE RESULTS. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER THE FALSE NEGATIVE RESULT MAY BE DUE TO THE PATIENT SAMPLE MATRIX. REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS WITHIN THE CLAIMS MADE IN THE PACKAGE INSERT AND HAVE NOT EXCEEDED THE UPPER CONTROL LIMIT FOR FURTHER ACTION.

    Additional Manufacturer Narrative · 1

    TESTING WAS UNABLE TO BE PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 114109 DUE TO ONGOING CONSTRUCTION ON SITE THAT PREVENTS ACCESS TO THE SPECIALIZED BLOOD TESTING LAB. A FOLLOW-UP REPORT WITH INVESTIGATION RESULTS WILL BE PROVIDED TO THE FDA WHEN COMPLETED. THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 114109 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE/NEGATIVE PATIENT RESULTS (INCLUDING CONFIRMED, UNCONFIRMED, AND CONFLICTING) FOR THIS SPECIFIC LOT BASED ON THE TOTAL DISTRIBUTED DEVICES IS (B)(4). BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THE LOT PERFORMING WITHIN LABEL CLAIMS OVERALL.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A FALSE NORMAL RESULT ON A KNOWN DEFICIENT PATIENT WITH THE BINAXNOW G6PD TEST. THE CUSTOMER REPORTED PREVIOUS TESTING ((B)(6) 2020) WAS REPORTED AS DEFICIENT WITH THE BINAXNOW G6PD TEST, CONFIRMED DEFICIENT BY SPECTROPHOTOMETRY BY THE (B)(6) CLINIC. THE PATIENT WAS REPORTED TO HAVE A HEMATOCRIT OF 31.9% AND WHITE BLOOD CELL COUNT OF 3,600 AT THE TIME OF THE (B)(6) 2020 TESTING. TESTING PERFORMED ON (B)(6) 2020 (EDTA WHOLE BLOOD COLLECTED (B)(6) 2020) GENERATED NORMAL RESULTS WITH THE BINAXNOW G6PD TEST. REPEAT TESTING WITH THE SAME SAMPLE, ON THE SAME KIT LOT, PERFORMED BY A DIFFERENT OPERATOR ALSO GENERATED NORMAL RESULTS ON THE BINAXNOW G6PD TEST. CONFIRMATION TESTING BY SPECTROPHOTOMETRY BY THE (B)(6) CLINIC WAS DEFICIENT. THE PATIENT WAS REPORTED TO HAVE A HEMATOCRIT OF 26.5% AND WHITE BLOOD CELL COUNT OF 22,900. THE CUSTOMER STATED THE PATIENT HAS CANCER (NOT OTHERWISE SPECIFIED) AND SICKLE CELL TRAIT, AND HAD BEEN ADMINISTERED WBC GROWTH STIMULATOR A FEW DAYS PRIOR TO THE (B)(6) 2020 TESTING. ATTEMPTS TO GAIN FURTHER INFORMATION WERE NOT SUCCESSFUL. A DIAGNOSIS OF G6PD DEFICIENCY IS MADE IN CONJUNCTION WITH OTHER CLINICAL TESTS AND INFORMATION AND NOT SOLELY ON THE OUTCOME OF THE BINAXNOW G6PD TEST RESULT. HOWEVER, IF PRIMAQUINE ANTI-MALARIAL DRUGS, SULFA DRUGS, OR ASCORBIC ACID ARE PRESCRIBED BASED ON THE BINAXNOW G6PD RESULT, CLINICAL COMPLICATIONS SUCH AS ACUTE HEMOLYTIC ANEMIA COULD DEVELOP. THIS CONDITION CAN BE SERIOUS AND LIFE-THREATENING, THEREFORE, THIS IS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693867 BINAXNOW G6PD TEST BINAXNOW G6PD JBF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 10811877010705

    Patients

    Seq Age Sex Outcome Treatment
    1