BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CLIP COVID RAPID ANTIGEN TEST

    MDR report key: 14463998 · Received May 20, 2022

    Report

    Report Number
    3015104453-2022-00024
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 29, 2022
    Report Date
    May 20, 2022
    Manufacturer
    LUMINOSTICS, INC DBA CLIP HEALTH
    Product Code
    QKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THREE REPORTED FALSE POSITIVES: 3/5 POSITIVES FROM APR 29 ARE ALLEGED FALSE POSITIVES PER PCR CONFIRMATION TESTING ON LUMIRADX. 2/3 PATIENTS WERE SYMPTOMATIC WITH LESS THAN 24 HRS SINCE SYMPTOM ONSET. A REVIEW OF THE BATCH RECORDS AND LOGGED FIELD RECORDS OF THE CUSTOMER LOT CC10766A DID NOT INDICATE ANY ISSUES WITH THE CARTRIDGE. FIELD DATA SHOWS PERFORMANCE THAT IS COMPARABLE TO IN HOUSE TESTING DATA. BASED ON REVIEW OF LOGS, FOUR SAMPLES RUN ON THE DATE IN QUESTION WERE RUN ABOVE THE LABELED UPPER OPERATING TEMPERATURE LIMIT (30). INVESTIGATION SUMMARY AND ROOT CAUSE ANALYSIS: THE CARTRIDGES WERE RUN OUTSIDE PRODUCT SPECIFICATIONS RANGE.

    Description of Event or Problem · 0

    CUSTOMER HAS RECEIVED NEW CASSETTES BUT STILL GETTING FALSE POSITIVES VERIFIED WITH RT-PCR TO BE NEGATIVE. THEY HAD 3 ON FRIDAY FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551397 CLIP COVID RAPID ANTIGEN TEST SARS-COV-2 ANTIGEN TEST QKP LUMINOSTICS, INC DBA CLIP HEALTH MDL001, CLIP ANALYZER AND MDL002, CLIP COVID RAPID ANTIGEN TEST KIT CC-10766-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown