BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW G6PD KIT

    MDR report key: 12701784 · Received October 26, 2021

    Report

    Report Number
    1221359-2021-03312
    Event Type
    Injury
    Date Received
    October 26, 2021
    Report Date
    September 20, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    JBF
    UDI-DI
    10811877010705
    PMA / PMN Number
    K161364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PREVIOUS REPORT AND PROVIDE THE INVESTIGATION CONCLUSION. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 780-000 / LOT 120558 AND DEVICE PART NUMBER 780-430 / LOT 119291. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS AND THERE WERE NO CONFLICTING RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4). BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THIS DEVICE LOT IS PERFORMING WITHIN LABEL CLAIMS. NO FURTHER ACTION IS REQUIRED. THE RETAIN KIT WAS TESTED 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 CONFLICTING RESULTS. THE CUSTOMER PROVIDED PHOTOGRAPHS FOR REVIEW: THE INVESTIGATOR REVIEWED THE CUSTOMER'S IMAGE OF A REPEATED TEST WITH A NEW BOX OF G6PD KIT, BOTH WERE NORMAL RESULTS. IN THE PHOTO TWO DEVICE CARDS ARE PRESENT. IT WAS OBSERVED THAT THE TOP CARD WAS LABELED AS 328R WITH TEMPERATURE AT 23.1C. THIS DEVICE HAS A DARK STRIP ON THE TOP WHICH REPRESENTS A NORMAL RESULT. ITS OBSERVED THAT THE BOTTOM CARD IS LABELED AS 328L WITH TEMPERATURE AT 23.1C. THIS DEVICE HAS A DARK STRIP ON THE TOP WHICH REPRESENTS A NORMAL RESULT. A SECOND SET OF IMAGES PROVIDED FROM THE CUSTOMER SHOWED A DISCREPANCY WITH NORMAL AND DEFICIENT RESULT. IN THIS PHOTO TWO DEVICE CARDS ARE PRESENT AS WELL. IT WAS OBSERVED THAT THE DEVICE ON TOP WAS LABELED AS 0328 (1) - THIS DEVICE HAS A DARK STRIP ON TOP WHICH REPRESENTS A NORMAL RESULT. THE DEVICE ON BOTTOM IS LABELED AS 0328 (2) - WITHOUT THE PHYSICAL DEVICE IN HAND WAS DIFFICULT TO SEE IN JUST THE PHOTO, BUT AT FIRST GLANCE IT APPEARED TO BE A DEFICIENT RESULT (NO COLOR CHANGE). BOTH DEVICES DO NOT HAVE THE TEMPERATURE RECORDED ON THE FRONT OF THE DEVICE, SO IT IS UNKNOWN IF THEY WERE RUN OUTSIDE OF THE TEMPERATURE LISTED. IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE REPORTED. THE CUSTOMER REPORTED THE SPECIMEN TYPE WAS EDTA WHOLE BLOOD THE IN LAB WHICH INCLUDED 24 TEST AND 15 FAILED. THE SAMPLES WERE NEWLY COLLECTED, AND PERFORM ON SAME DAY. IF SUSPECTED DEFICIENT, THE SAMPLE WOULD SEND OUT TO PERFORM QUANTITATIVE TEST. THE TEST DEVICES WERE NOT EXPOSED TO DIRECT SUNLIGHT OR PERFORM THE TEST NEAR A SUNNY WINDOW OR FLUORESCENT LIGHT FOR LONGER THAN 5 MINUTES PRIOR TO TESTING.

    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 USER REPORTED MULTIPLE DISCREPANCY RESULTS WERE FOUND IN SEVERAL CASES WHEN PERFORMING THE BINAXNOW G6PD KIT. THE CUSTOMER REPORTED THERE WAS ABOUT 7-8 CASES, THE FIRST RESULT SHOWED G6BP DEFFICIENT WHILE THE SECOND REPEAT TESTING SHOWED NORMAL. THE CUSTOMER REPORTED THAT THEY ALSO CONFIRMED RESULTS WITH A PARALLED RUN WITH QUANTITATIVE G6PD TEST USING A NEW BOX KIT AND TURN OUT ALL THE CASES WERE FOUND TO BE NORMAL. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599254 BINAXNOW G6PD KIT BINAXNOW G6PD KIT JBF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 120558 10811877010705

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other