BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 13909441 · Received March 25, 2022

    Report

    Report Number
    2024800-2022-00109
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 18, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOGS WERE UPLOADED AND TECHNICAL SUPPORT (TS) CONFIRMED THERE WERE NO HARDWARE ISSUES AND TS BELIEVED THIS COULD BE AN AMBIENT CONTAMINATION ISSUE. TS CONFIRMED THERE WERE NO REAGENT PREPARATION ISSUES FOUND. TS ADVISED TO DEEPLY CLEAN THE PREPARATION AREAS. NO FURTHER ISSUES WERE REPORTED.

    Additional Manufacturer Narrative · 0

    REPORT PROVIDED TO THE FDA ON (B)(6) 2022 WAS SUBMITTED AS A PRODUCT MALFUNCTION. THIS SUPPLEMENTAL REPORT IS TO UPDATE THE REPORT AS AN ADVESE EVENT BECAUSE BASED ON INFORMATION PROVIDED TO HOLOGIC ON (B)(6) 2022, THE IMPACTED PATIENT DEVELOPED COVID-19 DURING INCIDENT OCCURRENCE. ON (B)(6) 2022, A CUSTOMER REPORTED TO HOLOGIC THAT DURING A SARS-COV-2 RUN ON (B)(6) 2022, THEY ENCOUNTERED A POTENTIAL FALSE POSITIVE RESULT. CUSTOMER RETESTED THE SAMPLE AND RECEIVED A NEGATIVE RESULT IN THE SAME WORKLIST. CUSTOMER RELAYED THAT UPON PRIMARY POSITIVE RESULT, THE PATIENT WAS QUARANTINED AND COHORTED IN THE COVID-WARD OF THE HOSPITAL ALONGSIDE OTHER KNOWN POSITIVE PATIENTS. THE SAME SAMPLE SPECIMEN WAS ALSO TESTED ON NON-HOLOGIC INSTRUMENT (CEPHEID) AND YIELDED A NEGATIVE SARS-COV-2 RESULT. CUSTOMER OPTED TO RESAMPLE THE PATIENT WHILE IN QUARANTINE. THE NEW SAMPLE WAS ONLY TESTED ON A NON-HOLOGIC INSTRUMENT (CEPHEID) AND AGAIN YIELDED NEGATIVE RESULTS. BASED ON HOLOGIC'S INVESTIGATION A DEFINITIVE ROOT CAUSE COULD NOT BE CONFIRMED. POTENTIAL ROOT CAUSES ARE: - CONTAMINATION OF THE INITIAL LYSIS TUBE DUE TO INAPPROPRIATE OPERATOR SAMPLE HANDLING - GENUINE LOW POSITIVE INITIAL SAMPLE WITH A STATISTICAL CHANCE OF NEGATIVE RESULT UPON REPEAT TESTING.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TO HOLOGIC TECHNICAL SUPPORT (TS) THAT THEY HAD A FALSE POSITIVE RESULT FOR SARS-COV-2 TMA ASSAY, WL: (B)(4) ML: 308646, ON THE PANTHER INSTRUMENT. CUSTOMER STATED THAT THEY ORIGINALLY TESTED THE SAMPLE, AND IT WAS POSITIVE AND ACTED UPON IT WITH THE PATIENT. CUSTOMER STATED THAT THEY THEN TOOK FROM SAME SAMPLE, COLLECTED NEW SPECIMEN IN A NEW LYSIS TUBE, AND REMEASURED ON SAME INSTRUMENT AND SAME ML WITH A NEGATIVE RESULT.

    Description of Event or Problem · 0

    SUPPLEMENTAL_FINAL (SEE H10):

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885557 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 308646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other