BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENABIO

    MDR report key: 16103832 · Received January 5, 2023

    Report

    Report Number
    3016609999-2023-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 8, 2022
    Report Date
    January 5, 2023
    Manufacturer
    GENABIO DIAGNOSTICS INC
    Product Code
    QKP
    UDI-DI
    00196852953004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, A CUSTOMER CALLED REGARDING A DEFECT WITH OUR PRODUCT "GENABIO COVID-19 RAPID SELF-TEST KIT". THE USER REPORTED BROWNING OR DIRT LIKE SUBSTANCE ON THE SEALED NASAL SWAB. THE USER DID NOT USE THE PRODUCT AFTER DISCOVERING THIS ISSUE. THE USER PROVIDED US WITH THE LOT NUMBER OF THE PRODUCT AND EMAILED OUR SUPPORT ADDRESS WITH IMAGES OF THE DEFECT. WE DID NOT RECEIVE THE ORIGINAL PRODUCT FOR INVESTIGATION. AS PART OF OUR COMPLAINT INVESTIGATION, AN ADDITIONAL INVESTIGATION WAS CONDUCTED ON ITEMS REMAINING IN INVENTORY FROM THE AFFECTED LOT. NO NASAL SWABS WITH SIMILAR DEFECTIVE QUALITIES AS REPORTED WERE FOUND. WE WILL CONTINUE TO CLOSELY MONITOR THIS FOR ANY SIMILAR QUALITY ISSUES. IT IS CONCLUDED THAT THIS WAS AN ISOLATED INCIDENT, AS ANALYSIS OF PREVIOUS COMPLAINTS RESULT IN NO TREND OF SIMILAR ISSUES. SPONGE SWABS WILL GENERATE COLORED AZO COMPOUNDS DUE TO LIGHT, HEAT OR OXIDANTS, WHICH MAY CAUSE DISCOLORATION OF SAMPLING SWABS. ON THE PRODUCTION LINE, WE GENERALLY REJECT THIS KIND OF SWAB WHEN WE SEE IT, BUT VERY FEW TIMES IT WILL BE MISSED. IT IS BELIEVED THAT THIS INCIDENT IS A RESULT OF DISCOLORATION DUE TO AZO COMPOUNDS DUE TO LIGHT, HEAD OR OXIDANTS, NOT A BACTERIAL CONTAMINATION. THIS COULD BE A RESULT OF A MISSED QUALITY INSPECTION DURING MANUFACTURING. WE WILL CONTINUE TO MONITOR FOR THIS TYPE OF COMPLAINT AND OUR CONTRACTED MANUFACTURER AND QUALITY SERVICES WERE CONTACTED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A GENABIO DIAGNOSTICS CUSTOMER SUBMITTED A COMPLAINT VIA EMAIL INDICATING THAT THEY OPENED UP ONE OF THE GENABIO COVID TESTS AND DISCOVERED THAT THE SWAB WAS USED AND COVERED WITH BROWN STAINS. THEY CALLED OUR COMPANY TO REPORT THIS ON THE SAME DAY. THE LOT NUMBER PROVIDED BY THE CUSTOMER WAS US220925. A PICTURE OF THE SWAB WAS PROVIDED BY THE CUSTOMER (SEE ATTACHMENT). ON 16-DEC-2022 THE FDA INFORMED GENABIO DIAGNOSTICS THAT THE ISSUE HAD BEEN REPORTED TO THEM ON MEDWATCH REPORT NUMBER MW5113786.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131994 GENABIO GENABIO COVID-19 RAPID SELF TEST QKP GENABIO DIAGNOSTICS INC RA9-E00302 US220925 00196852953004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown