BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW G6PD KIT

    MDR report key: 18024455 · Received October 27, 2023

    Report

    Report Number
    1221359-2023-01594
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    September 1, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    JBF
    UDI-DI
    10811877010705
    PMA / PMN Number
    K161364
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT PROVIDED IN SECTION B3 IS AN APPROXIMATION, WAS NOT PROVIDED BY CONSUMER. D4 UDI: (B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 181228 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SAMPLES. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. NO FALSE NEGATIVE(NORMAL) RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 780-000 / LOT 195040, TEST BASE PART NUMBER 780-430 / LOT 194666. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 195040 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) FALSE NEGATIVE RESULTS WITH THE BINAXNOW G6PD KIT PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST THREE (3) OF FOUR (4). CONFIRMATION ELISA TESTING WAS PERFORMED ON AN UNKNOWN DATE, WHICH GENERATED A POSITIVE RESULT. REPEAT TESTING WAS PERFORMED THRICE ON THE SAME SAMPLE AND ONCE ON A NEW SAMPLE AT AN INTERVAL OF 2 WEEKS, WHICH EACH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THERE WAS AN IMPACT IN THE PATIENT'S TREATMENT; A DRUG CONTRAINDICATED FOR G6PD DEFICIENCY WAS PRESCRIBED AND TAKEN. THE NAME OF THE DRUG WAS NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WAS DEATH OR NO SERIOUS INJURY BASED ON THE TEST RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139178 BINAXNOW G6PD KIT GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING JBF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 195040 10811877010705

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other