BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 ANTIGEN

    MDR report key: 11863610 · Received May 21, 2021

    Report

    Report Number
    9680746-2021-00036
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 21, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THREE PATIENTS ARE INCLUDED IN THIS EVENT. 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. ¿NO ISSUES WITH TRANSPORT MEDIA WERE REPORTED IN CONNECTION WITH THE EVENT. ¿SARS-COV-2 IS AN ENVELOPED NON-SEGMENTED POSITIVE-SENSE RNA VIRUS. IT HAS SEVERAL STRUCTURAL PROTEINS INCLUDING SPIKE (S), ENVELOPE (E), MEMBRANE (M) AND NUCLEOCAPSID (N). THE SPIKE PROTEIN (S) CONTAINS A RECEPTOR BINDING DOMAIN (RBD) WHICH IS RESPONSIBLE FOR RECOGNIZING THE CELL SURFACE RECEPTOR, ANGIOTENSIN CONVERTING ENZYME-2 (ACE2). IT IS FOUND THAT THE RBD OF THE SARS-COV-2 S PROTEIN STRONGLY INTERACTS WITH THE HUMAN ACE2 RECEPTOR LEADING TO ENDOCYTOSIS INTO THE HOST CELLS AND VIRAL REPLICATION. THE ACCESS SARS-COV-2 ANTIGEN ASSAY DETECTS THE NUCLEOCAPSID PROTEIN TARGET. THE ACCESS SARS-COV-2 ANTIGEN INSTRUCTIONS FOR USE (DOCUMENT C69180 A) LIMITATIONS SECTION STATES, "POSITIVE TEST RESULTS DO NOT DIFFERENTIATE BETWEEN SARS-COV AND SARS-COV-2.¿ THE CEPHID XPERT EXPRESS SARS-COV-2 ASSAY DETECTS SARS-COV-2 TARGET RNA. THE TAQPATH SARS-COV-2 RESULT ON TAQPATH RT-PCR KIT TARGETS FOR SARS-COV-2 N GENE AND THE SARS-COV-2 S GENE. ¿ASSAY TECHNICAL SUPPORT PROVIDED THE CUSTOMER WITH TECHNICAL INFORMATION, INCLUDING DISCUSSING RECOMMENDATIONS TO REPEAT ASYMPTOMATIC POSITIVE RESULTS ON PCR METHODOLOGY. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS SHOULD NOT BE USED INTERCHANGEABLY AND DIFFERENCES BETWEEN METHODS ARE EXPECTED. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A REAGENT OR HARDWARE MALFUNCTION OCCURRED IN THIS EVENT.

    Additional Manufacturer Narrative · 0

    BEC TRACKING NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON(B)(6) 2021 THE CUSTOMER REPORTED POSITIVE SARS-COV-2 ANTIGEN (ACCESS SARS-COV-2 ANTIGEN ASSAY, PART NUMBER C68668, LOT NUMBER 971260) RESULTS WERE GENERATED FOR SEVERAL PATIENTS ON THE CUSTOMER'S ACCESS 2 IMMUNO ASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). THE RESULTS WERE QUESTIONED BECAUSE NEGATIVE RESULTS WERE OBTAINED ON PCR (POLYMERASE CHAIN REACTION) METHODOLOGY. REFER TO RELEVANT TEST/LABORATORY DATA SECTION BELOW FOR DATA PROVIDED BY CUSTOMER. THE CUSTOMER REPORTED THE PATIENTS WERE ASYMPTOMATIC. NO AFFECT TO PATIENTS OR END USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THREE (3) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS CUSTOMER REPORTS OF FALSE POSITIVE SARS COV-2 ANTIGEN RESULTS AT DIFFERENT DATES. THIS REPORT ADDRESSES PATIENT RESULTS OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER ¿9680746-2021-00036¿ WILL ADDRESS PATIENTS ONE, TWO AND THREE RESULTS OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER ¿9680746-2021-00037¿ WILL ADDRESS PATIENT FOUR RESULT OBTAINED ON (B)(6) 2021. MEDWATCH NUMBER ¿9680746-2021-00038¿ WILL ADDRESS PATIENT FIVE RESULT OBTAINED ON (B)(6) 2021. 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. ON (B)(6) 2021, A PASSING COVAG CALIBRATION WAS OBTAINED USING REAGENT LOT 971260 AND CALIBRATOR LOT 922853. COVAG QC (QUALITY CONTROL) RECOVERY WAS PROVIDED (B)(6) 2021. BOTH LEVELS OF COVAG QUALITY CONTROL RECOVERED WITHIN 2 SD OF THE CUSTOMER¿S STATED MEAN. ASSAY TECHNICAL SUPPORT RECOMMENDED THE CUSTOMER PERFORM CONTAMINATION PROTOCOL. THERE HAVE BEEN NO REPORTS OF CONFIRMED CONTAMINATION OCCURRING IN CONNECTION WITH THIS EVENT. NO ISSUES WITH TRANSPORT MEDIA WERE REPORTED IN CONNECTION WITH THE EVENT. THE CUSTOMER REPORTED UTM-RT TRANSPORT MEDIA WAS USED WITH HYDRAFLOCK STERILE FLOCKED COLLECTION SWABS. THE ACCESS SARS-COV-2 ANTIGEN INSTRUCTIONS FOR USE (DOCUMENT C69180 A), INTENDED USE SECTION STATES, ¿ACCESS SARS-COV-2 ANTIGEN ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF NUCLEOCAPSID ANTIGEN FROM SARS-COV-2 IN NASOPHARYNGEAL SWABS IN BARTELS® FLEXTRANS¿ TRANSPORT MEDIUM, COPAN UTM-RT®, PURITAN UNITRANZ-RT®UTM, REMEL MICROTEST¿ M4RT® OR SIGMA VIROCULT® TRANSPORT MEDIA FROM INDIVIDUALS WHO ARE SUSPECTED OF COVID-19 BY THEIR HEALTHCARE PROVIDER WITHIN THE FIRST SEVEN DAYS OF SYMPTOM ONSET.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758901 ACCESS SARS-COV-2 ANTIGEN CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CLARE DISCRETE MFG IO 971260 15099590742713

    Patients

    Seq Age Sex Outcome Treatment
    1