BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE

    MDR report key: 15715455 · Received November 2, 2022

    Report

    Report Number
    3016758165-2022-00215
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    June 12, 2022
    Report Date
    February 24, 2023
    Manufacturer
    CUE HEALTH INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA210180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: COMPLAINT HISTORY WAS REVIEWED AND THERE WERE NO PREVIOUS SIMILAR COMPLAINTS AGAINST INVOLVED LOT. THE LHR WAS REVIEWED AND THE LOT NUMBERS IN THE COMPLAINT PASSED QC RELEASE. A TECHNICAL SUPPORT REPRESENTATIVE REVIEWED CUSTOMER DATA AND PERFORMED DATA ANALYSIS. RETAINS OF THE CARTRIDGE LOT WERE TESTED AND REPRODUCED FALSE NEGATIVE RESULTS, HOWEVER, ROOT CAUSE WAS UNABLE TO BE DETERMINED. ADDITIONALLY, NO FURTHER INVESTIGATION WILL BE ABLE TO BE PERFORMED AS REMAINING CARTRIDGES ARE NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CARTRIDGES USED BY THE CONSUMER WERE NOT SENT BACK FOR EVALUATION, THEREFORE, THE DEVICES COULD NOT BE EVALUATED. THE CUSTOMER PROVIDED INFORMATION REGARDING THE SUSPECTED FALSE NEGATIVE TEST AND A MEMBER OF THE TECHNICAL SUPPORT GROUP WAS ABLE TO PERFORM DATA ANALYSIS. INVESTIGATION IS ONGOING AND A SUPPLEMENTARY REPORT WILL BE PROVIDED ONCE COMPLETE.

    Description of Event or Problem · 0

    ON (B)(6) 2022: CUSTOMER REPORTED THAT THEY RECEIVED A SUSPECTED FALSE NEGATIVE RESULT WITH THE CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE (CARTRIDGE SN: (B)(4), READER SN: (B)(4), LOT NUMBER: 21422M). ON (B)(6) 2022: CUSTOMER RECEIVED POSITIVE SARS-COV-2 ANTIGEN TEST ON AN UNSPECIFIED BRAND OF TEST. THE INDIVIDUAL HAD SYMPTOMS, FEVER COUGH, SORE THROAT AND KNOWN EXPOSURE. BOTH READER AND CARTRIDGES ARE BEING STORED AT ROOM TEMPERATURE. CUSTOMER RECEIVED REPLACEMENTS 10-PACK (ORDER#: 221424).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2913147 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. C2020 21422M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown