BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHOS DELTA

    MDR report key: 18256457 · Received December 4, 2023

    Report

    Report Number
    1000391282-2023-00001
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    July 3, 2023
    Report Date
    August 4, 2023
    Manufacturer
    MILESTONE SRL
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDICAL DEVICE PATHOS DELTA SERIAL NUMEBR (B)(6) IN (B)(6) 2023 AUTOMATED TISSUE PROCESSOR, TERMINATED WITH BAD TISSUE PROCESSING, UNDIAGNOSABLE. THE FACILITY WAS VISITED FOR TECHNICAL ANALYSIS IN (B)(6) 2023, WITHOUT ANY RELEVANT FINDINGS. MEDICAL DEVICE PATHOS DELTA SERIAL NUMEBR (B)(6) IN (B)(6) 2023 AUTOMATED TISSUE PROCESSOR, EXPERIENCED SAME AS IN (B)(6) 2023. THE FACILITY WAS VISITED FROM AN APPLICATION POINT OF VIEW IN (B)(6) 2023 WITH FINDINGS THAT THEIR ISOPROPANOL REAGENT CONTAINS MORE THAN 15% OF CONTAMINATION OF WATER (PURE MORE THAN 80%). FOR THE PROPER PURPOSE OF THE REAGENT, IT IS REQUIRED PURE REAGENT: GRADE MORE THAN 98%. THE FACILITY WHERE THE EVENT OCCURRED USES OTHER THREE DEVICES PATHOS DELTA. THE ISOPROPANOL IN THOSE DEVICES IS ADEQUATE, ALSO AFTER SOME PROCESSES WITH THE CONSEQUENCE OF THE REDUCTION OF PURITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503436 PATHOS DELTA AUTOMATED TISSUE PRCESSOR IEO MILESTONE SRL PATHOS DELTA NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other