BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2SARS-COV-2 PANEL (EUA)

    MDR report key: 14719754 · Received June 16, 2022

    Report

    Report Number
    3010097867-2022-00010
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    April 29, 2022
    Report Date
    June 16, 2022
    Manufacturer
    T2 BIOSYSTEMS, INC
    Product Code
    QJR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER DATA: ADVENT HEALTH WESLEY CHAPEL HAS REPORTED A TOTAL OF 12 RESULTS FOR THE T2SARS-COV-2 PANEL THAT ARE REPORTING DISCREPANT POSITIVE RESULTS WHEN COMPARED TO THE CEPHEID GENEXPERT. THESE WILL BE FILED AS INDEPENDENT REPORTABLE EVENTS AS EACH RESULT REPRESENTS AN INDEPENDENT PATIENT SAMPLE THAT IS INDEPENDENTLY ANALYZED ON THE T2DX DEVICE USING A SINGLE-USE REAGENT TRAY AND CARTRIDGE. ALL 12 RESULTS WERE RUN BETWEEN THE DATES OF (B)(6) 2022. RUN 10/12 HAS RUN ID 93A628D9-187B-493D-A701-EA75A7E4EFF2, IDENTIFIED BY THE LABORATORY STAFF AS HAVING PRODUCED A DISCREPANT POSITIVE RESULT THAT WAS REPORTED TO THE ATTENDING PHYSICIAN. THE CUSTOMER FURTHER REPORTED THAT TWO OF THE SIX DISCREPANT POSITIVE RESULTS REPORTED TO T2 BIOSYSTEMS ON (B)(6) 2022 CAUSED TWO PATIENTS TO HAVE THEIR SURGERIES CANCELLED, HOWEVER THEY DID NOT IDENTIFY WHICH OF THE RESULTS IMPACTED TREATMENT DECISIONS. AS AN ABUNDANCE OF CAUTION, T2 BIOSYSTEMS IS REPORTING ALL SIX TESTS AS HAVING POTENTIALLY IMPACTED PATIENT HEALTH. THE CUSTOMER HAS DECLINED TO PROVIDE ANY PATIENT DEMOGRAPHICS, HEALTH DETAILS, OR PATIENT OUTCOMES BEYOND WHAT HAS BEEN REPORTED IN THIS CASE. THE CUSTOMER HAS ALSO DECLINED TO PROVIDE THE TYPES OF SURGERIES, LENGTH OF DELAY, OR DIRECT OR INDIRECT IMPACT TO THE PATIENTS AS A RESULT OF THE ALLEGED DEVICE MALFUNCTION. THE CUSTOMER HAS DECLINED TO HAVE MEMBERS OF THE T2 BIOSYSTEMS FIELD APPLICATIONS TEAM ASSIST WITH FURTHER TROUBLESHOOTING OR ROOT CAUSE ANALYSIS. ALL OF THE FIELD DATA AND COMMERCIAL COMPLAINTS ASSOCIATED WITH THE T2SARS-COV-2 PANEL THAT HAVE BEEN PROVIDED TO T2 BIOSYSTEMS TO DATE HAVE BEEN REVIEWED WITH NO INDICATIONS THAT DISCREPANT RESULTS HAVE RECURRED FOR THESE REAGENTS AND CONSUMABLES. THIS POST-MARKET REVIEW OF CUSTOMERS WHO HAVE BEEN SHIPPED PRODUCT FROM THE SAME MANUFACTURING LOT HAS CONFIRMED THAT THE ALLEGED MALFUNCTION IS ISOLATED TO A SINGLE CUSTOMER AS REPORTED. INSTRUMENT EVALUATION: ON (B)(6) 2022, T2 BIOSYSTEMS DISPATCHED A FIELD SERVICE ENGINEER TO PERFORM AN INSTRUMENT ASSESSMENT AND CLEANING WITH NO FINDINGS RELATIVE TO INSTRUMENT PERFORMANCE AND POST-SERVICE CHECKOUT SAMPLES (ONE POSITIVE AND ONE NEGATIVE ZEPTOMETRIX CONTROL REPORTED RESULTS AS EXPECTED ON (B)(6) 2022. DEVICE EVALUATION: THE PRODUCTION AND QUALITY CONTROL TESTING RECORDS WERE SUBJECTED TO AN ADDITIONAL PRECAUTIONARY REVIEW WITH NO FINDINGS APPLICABLE TO LOT QUALITY OR PRODUCT PERFORMANCE. ALL INTERNAL PROCESSES WERE CONFIRMED TO HAVE BEEN PERFORMED WITH FULL ADHERENCE AND ALL MATERIAL SPECIFICATIONS WERE CONFIRMED TO HAVE BEEN MET UPON RELEASE. TO DETERMINE WHETHER THE DEVICE MALFUNCTION WAS REPRODUCIBLE IN HOUSE, INTERNAL TESTING WAS CONDUCTED AND CONFIRMED THAT REPRESENTATIVE SAMPLES OF THE T2SARS-COV-2 REAGENT LOT WO-20576 AND THE T2SARS-COV-2 CARTRIDGE LOT 92792035 ARE NOT PRODUCING DISCREPANT RESULTS WHEN RUNNING THE ZEPTOMETRIX NEGATIVE CONTROLS (ZEPTOMETRIX CORP. #NATSARS(COV2)-NEG) RECOMMENDED WITHIN THE T2SARS-COV-2 PRODUCT LABELING. AS SUCH, ALL INTERNAL PERFORMANCE EVALUATIONS CONFIRMED THAT THE MATERIAL IS PERFORMING IN ACCORDANCE WITH THE LABELING CLAIMS. CONCLUSION: THE ALLEGED DEVICE MALFUNCTION HAS BEEN CONFIRMED TO BE ISOLATED TO THE CONDITIONS PRESENT AT A SINGLE CUSTOMER SITE AND ARE NO TREFLECTED IN INTERNAL TESTING OR INVENTORY AT OTHER CUSTOMER SITES. BASED ON ALL AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE IS ASSOCIATED WITH SAMPLE HANDLING, STORAGE, OR OTHER ERRORS RELATED TO THE SAMPLE COLLECTION, PREPARATION, OR LOADING ONTO THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A REPRESENTATIVE FROM ADVENT HEALTH WESLEY CHAPEL REPORTED A PATIENT SAMPLE YIELDING A POSITIVE RESULT FOR SARS-COV-2 ON THE T2SARS-COV-2 EMERGENCY USE AUTHORIZED (EUA) PANEL HAD BEEN RUN THE DAY PROIR ON (B)(6) 2022. THE CUSTOMER REPEATED THE SAMPLE ON THE CEPHIED GENEXPERT AND OBTAINED A VALID NEGATIVE RESULT FOR THEIR SARS-COV-2 ASSAY ON (B)(6) 2022. THE DISCREPANT POSITIVE RESULT WAS REPORTED TO THE ATTENDING PHYSICIAN AND MAY HAVE RESULTED IN THE CANCELLATION OF A SURGERY. NO FURTHER INFORMATION REGARDING THE PATIENT HEALTH STATUS, INCLUDING THE SPECIFIC RUN IDENTIFICATION NUMBER IN WHICH PATIENT TREATMENT WAS IMPACTED, THE LENGTH OF THE DELAY TO TREATMENT, THE TYPE OF SURGERY, OR CLINICAL OUTCOME HAVE BEEN PROVIDED. THE DEVICE WAS EVALUATED BY A MEMBER OF THE T2BIOSYSTEMS FIELD SERVICE TEAM ON (B)(6) 2022 AND CONFIRMED THAT THE T2DX INSTRUMENT WAS OPERATING WITHIN ALL EXPECTED PERFORMANCE PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937662 T2SARS-COV-2 PANEL (EUA) MOLECULAR DIAGNOSTIC TEST FOR SARS-COV-2 QJR T2 BIOSYSTEMS, INC T2SARS-COV-2 PANEL (EUA) WO-20576

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown