BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA SARS COV2 ANTIGEN RAPID QUALITATIVE TEST

    MDR report key: 15652117 · Received October 21, 2022

    Report

    Report Number
    3017105091-2022-00022
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    July 19, 2022
    Report Date
    October 21, 2022
    Manufacturer
    INNOVA MEDICAL GROUP, INC
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: ONE COMPLAINT RECORD WAS CREATED AS THERE IS NO SPECIFICS ON THE NUMBER OF CASES REPORTED. THIS INVESTIGATION REPRESENTS THE UNKNOWN NUMBER OF CASES INDICATED IN THE PERFORMANCE OF LFDS REPORT. A PERFORMANCE REPORT FROM THE UK HEALTH SECURITY AGENCY WAS RECEIVED AND NOTED CONCERN REGARDING THE 25T TESTS' ABILITY TO DETECT COVID-19 POSITIVE RESULTS. NO SPECIFICS OF THE NUMBER OF CASES WERE PROVIDED. FOLLOW UP OF THIS CONCERN PROVIDED NO FURTHER INFORMATION ABOUT THE CIRCUMSTANCES, EXPIRY DATES, BATCH NUMBER OR THE CIRCUMSTANCES OF THE TESTING. CONSEQUENTLY, AS NO LOT NUMBER WAS AVAILABLE, A REVIEW OF BATCH, DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. POSSIBLE CONTRIBUTING FACTORS FOR A NEGATIVE TEST RESULT ARE KNOWN AS THE FOLLOWING: 1) UNPACKED TEST STRIPS HAVE BEEN LEFT TOO LONG, RESULTING IN MOISTURE; 2) SAMPLE WAS SPIKED TOO QUICKLY WITH TOO MUCH SAMPLE; THE SAMPLE WAS NOT DILUTED AT THE RIGHT MULTIPLE; 3) THE AMOUNT OF ANTIGEN IN A SAMPLE MAY DECREASE AS THE DURATION OF ILLNESS INCREASES. SPECIMENS COLLECTED AFTER DAY 5 OF ILLNESS ARE MORE LIKELY TO BE NEGATIVE COMPARED TO A RT-PCR ASSAY; AND 4) A FALSE NEGATIVE TEST RESULT MAY OCCUR IF THE LEVEL OF VIRAL ANTIGEN IN A SAMPLE IS BELOW THE DETECTION LIMIT [SENSITIVITY] OF THE TEST OR IF THE SAMPLE WAS IMPROPERLY COLLECTED (A POOR-QUALITY SPECIMEN IS OBTAINED). IT IS RECOMMENDED THAT THE TESTING KIT MUST BE OPERATED ACCORDING TO THE SPECIMEN COLLECTION AND ASSAY METHODS IN THE BODY OF THE INSTRUCTIONS FOR USE AND ADDITIONALLY, THE KIT SHOULD BE USED IMMEDIATELY AFTER OPENING THE LID. ACCORDING TO THE POST MARKET SURVEILLANCE REPORT 2022 (PMS-RPT-2022-001 V1), IT IS MUCH MORE LIKELY THAT FALSE NEGATIVE RESULTS WILL BE CAUSED BY AN INSUFFICIENT SAMPLE (LOW AMOUNT OF ANALYTE) OR DUE TO CLINICAL SPECIMENS THAT CONTAIN LOW VIRAL LOADS (<106 RNA COPIES/ML) WITH ANALYTE NEAR THE LIMIT OF DETECTION OF THE TEST. WITH THE LIMITED, THE ABSENCE OF FURTHER, INFORMATION ABOUT THE CIRCUMSTANCES (INCLUDING BUT NOT LIMITED TO STORAGE CONDITIONS, EXECUTION OF TEST STEPS, ONSET OF SYMPTOMS, IF ANY, AND TEST DATES, THE CAUSE OF THE REPORTED CASES COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ACCORDING TO A UK HEALTH SECURITY AGENCY PERFORMANCE OF LFDS REPORT, CONCERNS REGARDING TEST PERFORMANCE WAS NOTED, SPECIFICALLY THE ABILITY TO PICK UP POSITIVE RESULTS (COVID-19 DETECTION). BETWEEN MID AND END OF (B)(6) 2022, THREE EMAIL REPORTS OF CONCERNS ABOUT THE PERFORMANCE OF LFDS FOR DETECTION OF COVID-19 WERE RECEIVED. ONE OF THESE REPORTS CONCERNED INNOVA 25T TESTS IN WHICH A PUBLIC HEALTH CONSULTANT HAD REPORTED THAT LOCAL GPS RAISED ISSUES WITH THE INNOVA 25S ABILITY TO DETECT POSITIVE RESULTS. NO SPECIFICS OF THE NUMBER OF CASES WERE REPORTED. FOLLOW-UP OF THESE CONCERNS PROVIDED NO FURTHER INFORMATION ABOUT THE CIRCUMSTANCES, EXPIRY DATES, BATCH NUMBER OR THE CIRCUMSTANCES OF THE TESTING. SINCE THEN, NO FURTHER CONCERNS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021071 INNOVA SARS COV2 ANTIGEN RAPID QUALITATIVE TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP INNOVA MEDICAL GROUP, INC BT1309

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown