BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATIONONE®CDX

    MDR report key: 24772329 · Received April 2, 2026

    Report

    Report Number
    3010679023-2026-00002
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    January 31, 2026
    Report Date
    April 2, 2026
    Manufacturer
    FOUNDATION MEDICINE, INC.
    Product Code
    PQP
    PMA / PMN Number
    P170019
    Removal / Correction Number
    RES# 98625 / 3010679023-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOUNDATION MEDICINE (FMI) IDENTIFIED AN ISSUE THAT IMPACTED SIX (6) F1CDX PATIENT REPORTS ISSUED RESULTING IN A FALSE-POSITIVE BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS WHICH WAS REPORTED AS A TUMOR PROFILING FINDING DUE TO A MANUFACTURER DEFECT ASSOCIATED WITH A COMPONENT USED DURING SEQUENCING. INFORMATION WAS RECEIVED FROM THE MANUFACTURER OF THE COMPONENT ON 05MAR2026 THAT REASONABLY SUGGESTED THAT THERE WAS A DEVICE MALFUNCTION THAT HAD CAUSED THIS BARD1 ARTIFACT FALSE-POSITIVE. PRIOR TO 05MAR2026, FMI HAD BEEN INVESTIGATING WHETHER THE ISSUE WAS POTENTIALLY RELATED TO REAGENT HANDLING/STORAGE IN FMI'S CLINICAL LABORATORIES. ALTHOUGH THESE VARIANTS WERE NON-ACTIONABLE ON THE F1CDX REPORTS IMPACTED (I.E. DID NOT HAVE AN ASSOCIATED COMPANION DIAGNOSTIC TREATMENT), IF THIS ISSUE WERE TO REOCCUR WHILE TESTING A PROSTATE CANCER SAMPLE, A FALSE-POSITIVE COMPANION DIAGNOSTIC RESULT FOR OLAPARIB COULD THEORETICALLY OCCUR. THIS COULD LEAD TO INAPPROPRIATE TREATMENT WITH OLAPARIB, WITH POTENTIAL FOR DRUG-RELATED ADVERSE REACTIONS AND/OR DISEASE PROGRESSION, REQUIRING A MEDICAL INTERVENTION TO CHANGE TREATMENT TO EFFECTIVE OPTIONS.

    Description of Event or Problem · 0

    ON 31 JAN 2026, THE FOUNDATION MEDICINE, CLINICAL BIOINFORMATICS OPERATIONS (CBO) TEAM FLAGGED DNA SEQUENCING MASTER POOL (B)(6) (ANALYSIS WORKFLOW: (B)(6) PROD) FOR THE PRESENCE OF POTENTIAL BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS. THE INVESTIGATION DETERMINED THAT AN INCREASED FREQUENCY OF BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS, PRESENT IN A HOMOPOLYMER SEQUENCE REGION, WAS CORRELATED WITH THE USE OF SUPPLIER PROVIDED REAGENT SEQ0067 WITH LOT NUMBERS: 24346, 24386, 24488. SIX (6) F1CDX REPORTS ASSOCIATED WITH THE USE OF ILLUMINA SBS CARTRIDGE LOT NUMBER: 20964146 WERE REPORTED OUT WITH FALSE-POSITIVE BARD1 SPLICE SITE INDEL ARTIFACT VARIANTS AND WERE LATER AMENDED. NO EXTERNAL COMPLAINT OR ADVERSE EVENT WAS REPORTED FOR THIS PATIENT. ON 05MAR2026, THE SUPPLIER OF SEQ0067 PROVIDED FOUNDATION MEDICINE WITH A CUSTOMER NOTIFICATION THAT DESCRIBED A MANUFACTURER DEFECT WITH SIX (6) VENDOR LOTS. OF THE SIX (6) IMPACTED VENDOR LOTS, ONLY ONE VENDOR LOT WAS RECEIVED BY FOUNDATION MEDICINE, WHICH WAS INTERNALLY IDENTIFIED AS NUMBERS 24346, 24386, 24488.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469593 FOUNDATIONONE®CDX No Match PQP FOUNDATION MEDICINE, INC. SEQ0067 24346 / 24386 / 24488

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female