BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION SARS-COV-2

    MDR report key: 14739643 · Received June 17, 2022

    Report

    Report Number
    2024800-2022-01019
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 17, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD SERVICE ENGINEER (FSE) REPLACED THE PANTHER SAMPLE PIPETTOR TO RESOLVE THE PRECIPITATE BUILDUP ISSUE. VERIFICATIONS PASSED AND THE INSTRUMENT WAS RELEASED TO THE CUSTOMER. SOURCE OF CONTAMINATION IS INDETERMINATE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CUSTOMER REPORTED TO HOLOGIC TECHNICAL SUPPORT (TS) THAT THE PANTHER INSTRUMENT SN (B)(4) SAMPLE SHIELD HAS ABNORMAL PRECIPITATE/UNKNOWN BUILDUP ON IT. CUSTOMER NOTICED THE BUILDUP WHILE PERFORMING MAINTENANCE AND WONDERED IF IT WAS NORMAL. CUSTOMER STATED THAT THEY WERE CURRENTLY DEALING WITH A POSSIBLE CONTAMINATION OF THE INSTRUMENT AND WONDERED IF THE TWO WERE RELATED. CUSTOMER REPLACED THE SAMPLE SHIELD. THE INSTRUMENT ONLY PROCESS SARS-COV-2 ASSAY PPR AND 6 WORKLISTS WERE IN QUESTION (EACH WORKLIST WILL BE REPORTED AS SEPARATE MDR). HOLOGIC REVIEWED WL (B)(4) THAT USED ASSAY LOT 304642. THE WORKLIST HAS 21/182 POSITIVE RESULTS. PRODUCT APPLICATION SPECIALIST (PAS) REVIEWED THE WORKLIST TO TRY AND FIND A PATTERN OF CONTAMINATION, BUT THE POSITIVE RESULTS ARE IN RANDOM TUBES THROUGHOUT. ALL THE RUNS ARE VALID AND THERE ARE NO REAGENT PREPARATION ISSUES. CUSTOMER SENT PHOTOS OF DIRTY SAMPLE SHIELD, BUT SINCE THE SAMPLE SHIELD WAS ALREADY REPLACED, IT WAS NOT POSSIBLE FOR PAS TO DEFINITIVELY IDENTIFY WHAT SAMPLES COULD HAVE BEEN CONTAMINATED. CUSTOMER WAS ADVISED TO RERUN THE POSITIVE RESULTS. CUSTOMER DID NOT PROVIDE INFORMATION IF THE RESULTS WERE RETESTED. TS FOLLOWED UP WITH THE CUSTOMER ON (B)(6) 2022. CUSTOMER REPORTED THAT CARETAKER FACILITY STAFF WHO TEST WEEKLY RECEIVED 7 POSITIVE RESULTS. PATIENTS QUESTIONED THE RESULTS AND REPORTED TO THE COLLECTION SITE THEY THE PATIENTS WERE RETESTED BY A DIFFERENT TEST AND RECEIVED NEGATIVE RESULTS. BECAUSE PATIENT QUESTIONED THE RESULTS, NO TREATMENT WAS PROVIDED. THE COLLECTION SITE NOTIFIED THE TESTING SITE ABOUT THE DISCREPANCY. CUSTOMER (TESTING SITE) RETESTED THE ORIGINAL SAMPLE AND A NEW ALIQUOT OF THE 7 SAMPLES IN QUESTION AND BOTH RETESTED NEGATIVE. CUSTOMER AMENDED THE INITIAL REPORT. CUSTOMER DID NOT PROVIDE THE SPECIFIC SAMPLE IDS OR WLS WHERE THE DISCREPANT RESULTS CAME FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716951 FUSION SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID OJR HOLOGIC, INC. 304642

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown