BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISION FLEX HEMATOXYLIN (LINK)

    MDR report key: 12308027 · Received August 11, 2021

    Report

    Report Number
    3003423869-2021-00260
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 15, 2021
    Report Date
    September 16, 2022
    Manufacturer
    AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.
    Product Code
    HYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HEMATOXYLIN DID NOT PERFORM AS INTENDED. THIS MAY RESULT IN POTENTIAL ALTERATION TO THE STAINING INTENSITY WHICH MAY LEAD TO INCORRECT RESULTS. NO ERRONEOUS STAINING RESULT WAS REPORTED BY THE CUSTOMER IN CONNECTION WITH THIS INCIDENT. NO PATIENT OR USER HARM WAS INDICATED. CAPA00885 WAS OPENED BY AGILENT TECHNOLOGIES TO INVESTIGATE THE ISSUE OF WEAK COUNTERSTAINING. THROUGH THIS INVESTIGATION IT WAS DETERMINED THAT THE INITIAL ISSUE OF WEAK STAINING OF HEMATOXYLIN WAS DUE TO 2 CONTRIBUTING FACTORS. THE FIRST ROOT CAUSE, FOUND DURING SCAR00418'S INVESTIGATION, WAS DETEMINED TO BE AGILENT'S SUPPLIER MANUFACTURING TWO PRODUCTION RUNS (WITH 15 DAYS IN BETWEEN) FROM ONE RAW MATERIAL LOT. THE OTHER ROOT CAUSE WAS DETERMINED TO BE AGILENT'S INTERNAL ACCEPTANCE CRITERIA. WHILE THE RECEIVED PRODUCT PASSED CURRENT SPECIFICATIONS IT WAS DECIDED THIS CRITERIA IS TO VAGUE, LACKS GRADUATION DURING EVALUATION, AND IS DECIDED WITH A YES/NO DECISION. DURING ACCEPTANCE CRITERIA REVIEW IT WAS SHOWN THAT "MACROSCOPICALLY, THE HEMATOXYLIN-SLIDE IS VERY WEAKLY STAINED, BUT MICROSCOPICALLY BLUE NUCLEI CAN BE SEEN AND THERE IS DISTINCT "NUCLEI-DETAILS" TO BE SEEN." ALL AFFECTED COUNTRIES HAD THE APPROPRIATE REGULATORY AUTHORITIES CONTACTED AND ALL FSCA HAVE NOW BEEN CLOSED WITH ALL REQUIRED DOCUMENTATION. A RECALL WAS NOT CONDUCTED IN THE UNITED STATES AS THE AFFECTED LOT WAS NOT DISTIBUTED IN THE UNITED STATES. A NOTIFICATION WAS SENT TO ALL AFFECTED CUSTOMERS NOTIFYING THEM TO IMMEDIATELY STOP THE USE OF THE PRODUCT AND REQUEST A REPLACEMENT. THE LEVEL OF EFFECTIVENESS CHECK WAS LEVEL A--100 PERCENT OF THE TOTAL NUMBER OF CONSIGNEES TO BE CONTACTED. THE EFFECTIVENESS OF AN FSCA IS MEASURED BY THE TOTAL NUMBER OF RETURN FORMS RECEIVED FROM THE CUSTOMERS AS WELL AS THE NUMBER OF CUSTOMERS CLOSED BY A MINIMUM OF 3 GOOD FAITH EFFORT (GFE). AGILENT'S SUPPLIER CONFIRMED THAT MOVING FORWARD THERE WILL BE ONE LOT PER PRODUCTION RUN; ADDITIONALLY SUPPLIER WILL NOW ALSO PROVIDE DATA FOR ABSORBANCE ON THE COA. THE FOLLOWING CORRECTION HAS BEEN IMPLEMENTED TO PREVENT RECURRENCE: A NEW QC TEST WITH RELATED NEW ACCEPTANCE CRITERIA WILL BE IMPLEMENTED. THE TEST WILL CONSIST OF A HEMATOXYLIN STAINING, AN OD-, AND A PH MEASUREMENT TEST. A1-A6: PATIENT INFORMATION HAS NOT BEEN PROVIDED BY THE USER.

    Description of Event or Problem · 0

    THE JAPAN CUSTOMER REPORTED WEAK HEMATOXYLIN COUNTERSTAINING USING PD-L1 ASSAYS. IN THIS EVENT, THE STAINING ABERRATION WAS DETECTED BY THE USER AND TEST RESULT WAS INVALIDATED. REPLACEMENT WAS PROVIDED WHICH RESOLVED THIS ISSUE. NO PATIENT HARM WAS INDICATED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE ROOT CAUSE IS CURRENTLY UNDER INVESTIGATION. FAILURE MODE DESCRIPTION: THE HEMATOXYLIN DID NOT PERFORM AS INTENDED. THIS MAY RESULT IN POTENTIAL ALTERATION TO THE STAINING INTENSITY WHICH MAY LEAD TO INCORRECT RESULTS. ONCE ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECORD REPORTED WEAK HEMATOXYLIN COUNTERSTAINING USING PD-L1 ASSAYS. IN THIS EVENT, THE STAINING ABERRATION WAS DETECTED BY THE CUSTOMER AND TEST RESULT WERE INVALIDATED. NO PATIENT HARM WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203817 ENVISION FLEX HEMATOXYLIN (LINK) DYE AND CHEMICAL SOLUTION STAINS. HYJ AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. K8008 41246596

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown