BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 ANTIGEN

    MDR report key: 11885032 · Received May 26, 2021

    Report

    Report Number
    9680746-2021-00041
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 6, 2021
    Report Date
    August 12, 2021
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKP
    UDI-DI
    15099590742713
    Removal / Correction Number
    Z-2255-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 ANTIGEN REAGENT WAS NOT RETURNED FOR EVALUATION. ¿AVAILABLE SYSTEM PERFORMANCE INDICATOR OF PASSING QUALITY CONTROL RECOVERY DID NOT DEMONSTRATE AN ISSUE WITH THE SYSTEM. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. ¿THE CUSTOMER IS RUNNING BD LIQUID AMIES FOR THEIR TRANSPORT MEDIA, WHICH IS NOT AN APPROVED MEDIA TYPE FOR THE SARS-COV-2 ANTIGEN ASSAY. CUSTOMER INQUIRED ON HOW THEY COULD VALIDATE THE MEDIA. APPLICATION TECHNICAL SUPPORT (ATS) MANAGER, (B)(6), ADVISED THEY WOULD NEED TO DO A DUAL SWAB COLLECTION WITH AN APPROVED MEDIA. CUSTOMER WOULD LIKE THE CARE KIT OF COPAN MEDIA AND SWABS SENT TO THEM IN ORDER TO PERFORM THE DUAL SWAB COMPARISON. ATS SENT COPAN SWABS AND MEDIA FOR EVALUATION. A CONTAMINATION VERIFICATION PROTOCOL WAS ALSO SENT. ¿ATS ALSO OFFERED TO TEST THE SAMPLE. THE CUSTOMER DID NOT HAVE ANY SAMPLE LEFT. HE RECOMMENDED TO TEST THE PATIENT ON SEROLOGY ASSAYS. HE ALSO ASSISTED IN EVALUATING THE TRANSPORT MEDIA. THE CUSTOMER DID NOT REPORT FURTHER ISSUE WITH THE ASSAY. IN CONCLUSION, THERE IS EVIDENCE OF A USE ERROR AS THE CUSTOMER IS NOT USING AN APPROVED TRANSPORT MEDIA. AN ALTERNATIVE TRANSPORT MEDIA WAS SENT TO THE CUSTOMER. NO UPDATE WAS RECEIVED FROM THE CUSTOMER REGARDING VALIDATION OF THE MATERIAL RECOMMENDED.

    Additional Manufacturer Narrative · 0

    BEC TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED FALSE REPEATABLE POSITIVE SARS-COV-2 ANTIGEN (ACCESS SARS-COV-2 ANTIGEN ASSAY, PART NUMBER C68668, LOT NUMBER 971258) RESULTS WERE GENERATED FOR ONE PATIENT ON THE CUSTOMER'S UNICEL DXI 600 ACCESS IMMUNO ASSAY ANALYZER (PART NUMBER A30260 AND SERIAL NUMBER 901848). ON (B)(6) 2021 THE REPEATABLE FALSE POSITIVE SARS-COV-2 ANTIGEN RESULTS FOR ONE PATIENT SAMPLE WERE 23.77 S/CO (08:10 PM), 23.33 S/CO (08:11 PM) AND 12.81 S/CO (08:49 PM). THE RESULTS WERE DISCORDANT TO AN ALTERNATE TEST (UNKNOWN) AND PCR. NO AFFECT TO PATIENTS OR END USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. CALIBRATION PASSED ON 6APR2021 WITH REAGENT LOT 971258 AND CALIBRATOR LOT 922853. QUALITY CONTROL WAS WITHIN SPECIFICATIONS. THE CUSTOMER IS RUNNING BD LIQUID AMIES FOR THEIR TRANSPORT MEDIA, WHICH IS NOT AN APPROVED MEDIA TYPE FOR THE SARS-COV-2 ANTIGEN ASSAY. CUSTOMER INQUIRED ON HOW THEY COULD VALIDATE THE MEDIA. APPLICATION TECHNICAL SUPPORT (ATS) MANAGER, (B)(6), ADVISED THEY WOULD NEED TO DO A DUAL SWAB COLLECTION WITH AN APPROVED MEDIA. CUSTOMER WOULD LIKE THE CARE KIT OF COPAN MEDIA AND SWABS SENT TO THEM IN ORDER TO PERFORM THE DUAL SWAB COMPARISON. ATS SENT COPAN SWABS AND MEDIA FOR EVALUATION. A CONTAMINATION VERIFICATION PROTOCOL WAS ALSO SENT. ATS ALSO OFFERED TO TEST THE SAMPLE. THE CUSTOMER DID NOT HAVE ANY SAMPLE LEFT. HE RECOMMENDED TO TEST THE PATIENT ON SEROLOGY ASSAYS. HE ALSO ASSISTED IN EVALUATING THE TRANSPORT MEDIA. THE CUSTOMER DID NOT REPORT FURTHER ISSUE WITH THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782610 ACCESS SARS-COV-2 ANTIGEN CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CLARE DISCRETE MFG IO 971258 15099590742713

    Patients

    Seq Age Sex Outcome Treatment
    1