BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUE COVID-19 TEST CARTRIDGE PACK, HOME & OTC, 10-PK

    MDR report key: 15289944 · Received August 24, 2022

    Report

    Report Number
    3016758165-2022-00115
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    February 16, 2022
    Report Date
    January 25, 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

    CARTRIDGES USED BY THE CONSUMER WERE NOT SENT BACK FOR EVALUATION, THEREFORE, CUE HEALTH INC. COULD NOT EVALUATE THE DEVICES. HOWEVER, CUSTOMER PROVIDED INFORMATION REGARDING THE SUSPECTED FALSE POSITIVE TESTS AND A MEMBER OF THE TECHNICAL SUPPORT GROUP WAS ABLE TO PERFORM DATA ANALYSIS. A TECHNICAL SUPPORT REPRESENTATIVE REVIEWED CUSTOMER DATA AND NOTED THAT THE CUE READER WAS PERFORMING WITHIN SPECIFICATIONS. TO BETTER ADDRESS FALSE POSITIVE TEST RESULTS, THE CUE READER FIRMWARE WAS UPGRADED TO VERSION 0.17.7, RELEASED IN LATE DECEMBER 2021, TO DETECT AND CANCEL THE TEST INSTEAD OF RELEASING FALSE POSITIVE RESULTS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H10: THE COMPLAINT HISTORY WAS REVIEWED AND THERE WERE THREE SIMILAR COMPLAINTS AGAINST INVOLVED LOT. THE LOT HISTORY RECORD (LHR) WAS REVIEWED FOR THE LOT NUMBER IN THE COMPLAINT, AND IT PASSED RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    UPDATE TO G4: PMA/510(K) NUMBER ADDED CORRECTION TO B3: DATE OF OCCURRENCE UPDATED TO 16-FEB-2022. CORRECTION TO H10: EXPLANATION FOR H3: CARTRIDGES USED BY THE CONSUMER WERE NOT SENT BACK FOR EVALUATION, THEREFORE, CUE HEALTH INC. COULD NOT EVALUATE THE DEVICES. HOWEVER, CUSTOMER PROVIDED INFORMATION REGARDING THE SUSPECTED FALSE POSITIVE TESTS AND A MEMBER OF THE TECHNICAL SUPPORT GROUP WAS ABLE TO PERFORM DATA ANALYSIS. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WERE NO SIMILAR COMPLAINTS AGAINST INVOLVED LOT. THE LOT HISTORY RECORD (LHR) WAS REVIEWED FOR THE LOT NUMBER IN THE COMPLAINT, AND IT PASSED RELEASE SPECIFICATIONS. A TECHNICAL SUPPORT REPRESENTATIVE REVIEWED CUSTOMER DATA AND PERFORMED DATA ANALYSIS. ALL DATA VALUES WERE NORMAL AND MET ACCEPTABLE CRITERIA. ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CUSTOMER REPORTED MULTIPLE HIGH FREQUENCY OF FALSE POSITIVE, INVALID AND CANCELED TESTS FOR MULTIPLE INDIVIDUALS. CUSTOMER REPORTED 15 SUSPECTED FALSE POSITIVES. THIS MANUFACTURER'S REPORT ADDRESSES PATIENT 6 OF 15. THE CUSTOMER REPORTED A FALSE POSITIVE WITH THE CUE COVID-19 TEST CARTRIDGE PACK, HOME & OTC, 10-PK. NO ADDITIONAL INFORMATION REGARDING REPEAT TESTING ON THE PATIENT, OR IF ANY CONFIRMATORY TESTING WAS PERFORMED. CIRCUMSTANCES REGARDING THE PATIENT'S CONDITION, INCLUDING TREATMENT AND OUTCOME, IF ANY, WERE NOT PROVIDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTS FIFTEEN FALSE POSITIVE RESULTS WHEN TESTING WITH THE CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE. THIS REPORT IS TO DOCUMENT ONE OF THE FALSE POSITIVE RESULTS OBTAINED. SEE RELATED CASES FOR ALTERNATE FALSE POSITIVE RESULTS. CUSTOMER REPORTS INDIVIDUAL RECEIVED A FALSE POSITIVE RESULT ON 16-FEB-2022 WHEN TESTING USING THE CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE (CARTRIDGE SN (B)(6), LOT 22249K, READER SN (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273504 CUE COVID-19 TEST CARTRIDGE PACK, HOME & OTC, 10-PK REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. C2020 22249K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown