BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-FLASH

    MDR report key: 21031210 · Received December 27, 2024

    Report

    Report Number
    2026994-2024-00001
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    November 14, 2024
    Report Date
    March 6, 2025
    Manufacturer
    BIOKIT S.A.
    Product Code
    JPA
    UDI-DI
    08426950639725
    PMA / PMN Number
    K170314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED UPON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE CAUSE OF THE REPORTED EVENT IS LIKELY RELATED TO INSTRUMENT PERFORMANCE. THE INSTRUMENT LOG REVIEW CONCLUSION WAS THAT A COMBINATION OF ERRORS OBSERVED IS SUGGESTIVE THAT INSTRUMENT PERFORMANCE AT THE TIME OF THE INITIAL TEST RESULTS COULD HAVE IMPACTED SAMPLE RESULTS. AN INOVA FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE PERFORMED MULTIPLE ALIGNMENTS, MAINTENANCE PROCESSES, AND PART REPLACEMENTS; INSTRUMENT PERFORMANCE WAS VERIFIED AND THE CUSTOMER WAS NOTIFIED THAT THE ANALYZER WAS READY FOR USE. DUE TO MULTIPLE INTERVENTIONS PERFORMED, A SPECIFIC PART CANNOT BE IDENTIFIED AS THE SOLE CONTRIBUTOR OF THIS EVENT. A FAILURE OF ONE OR MORE OF THE INSTRUMENT COMPONENTS IS THE MOST LIKELY CAUSE OF THIS EVENT. NO FURTHER ISSUES HAVE BEEN NOTED FOLLOWING THE SERVICING OF THE INSTRUMENT.

    Description of Event or Problem · 0

    THE QUANTA FLASH® GBM IS A CHEMILUMINESCENT IMMUNOASSAY (CIA) FOR THE SEMI-QUANTITATIVE DETECTION OF IGG ANTI-GLOMERULAR BASEMENT MEMBRANE (GBM) AUTOANTIBODIES IN HUMAN SERUM ON THE BIO-FLASH® INSTRUMENT. QUANTA FLASH® GBM IS AN AID IN THE DIAGNOSIS OF GOODPASTURE'S SYNDROME IN CONJUNCTION WITH CLINICAL FINDINGS AND OTHER LABORATORY TESTS. COMPLAINT (B)(4) REPORTED THAT A PATIENT WITH ACUTE KIDNEY INJURY PRESENTED WITH A NEGATIVE QUANTA FLASH GBM REAGENT (LOT NUMBER 244154) RESULT ON (B)(6) 2024. ON (B)(6) 2024 THE SAMPLE WAS RETESTED USING THE PHADIA MPO AND PR-3 ASSAYS, WHICH TESTED LOW POSITIVE FOR MPO AND NEGATIVE FOR PR-3. A BIOPSY WAS ORDERED (DATE UNKNOWN) BASED UPON THE PHADIA LOW POSITIVE MPO TEST RESULT. THE BIOPSY WAS POSITIVE FOR IGG ANTI-GLOMERULAR BASEMENT MEMBRANE (GBM) DISEASE. PLEX TREATMENT (PLASMA EXCHANGE) WAS ADMINISTERED FOLLOWING THE BIOPSY RESULTS. HOWEVER, THE CUSTOMER REPORTED THAT THE DELAY IN DIAGNOSIS LED TO IRREVERSIBLE DESTRUCTION OF ORGAN AND PERMANENT NEED FOR DIALYSIS.

    Description of Event or Problem · 0

    THE QUANTA FLASH® GBM IS A CHEMILUMINESCENT IMMUNOASSAY (CIA) FOR THE SEMI-QUANTITATIVE DETECTION OF IGG ANTI-GLOMERULAR BASEMENT MEMBRANE (GBM) AUTOANTIBODIES IN HUMAN SERUM ON THE BIO-FLASH® INSTRUMENT. QUANTA FLASH GBM IS AN AID IN THE DIAGNOSIS OF GOODPASTURE'S SYNDROME IN CONJUNCTION WITH CLINICAL FINDINGS AND OTHER LABORATORY TESTS. COMPLAINT (B)(4) REPORTED THAT A PATIENT WITH ACUTE KIDNEY INJURY PRESENTED WITH A NEGATIVE QUANTA FLASH GBM REAGENT (LOT NUMBER 244154) RESULT ON (B)(6) 2024. ON (B)(6) 2024 THE SAMPLE WAS RETESTED USING THE PHADIA MPO AND PR-3 ASSAYS, WHICH TESTED LOW POSITIVE FOR MPO AND NEGATIVE FOR PR-3. A BIOPSY WAS ORDERED (DATE UNKNOWN) BASED UPON THE PHADIA LOW POSITIVE MPO TEST RESULT. THE BIOPSY WAS POSITIVE FOR IGG ANTI-GLOMERULAR BASEMENT MEMBRANE (GBM) DISEASE. PLEX TREATMENT (PLASMA EXCHANGE) WAS ADMINISTERED FOLLOWING THE BIOPSY RESULTS. HOWEVER, THE CUSTOMER REPORTED THAT THE DELAY IN DIAGNOSIS LED TO IRREVERSIBLE DESTRUCTION OF ORGAN AND PERMANENT NEED FOR DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433382 BIO-FLASH SYSTEM MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES JPA BIOKIT S.A. 244154 08426950639725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| S