BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENZYME SOLUTION PAPAIN ORTHO SERA

    MDR report key: 16984021 · Received May 23, 2023

    Report

    Report Number
    3011683976-2023-00001
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 23, 2023
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    KSK
    UDI-DI
    10758750030330
    PMA / PMN Number
    BK150246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ORTHO¿ SERA PAPAIN IS USED TO ENHANCE REACTIVITY OF ORTHO¿ SERA RED BLOOD CELL ANTIGEN TYPING REAGENTS AND RED BLOOD CELLS WHEN USED IN IN-VITRO IMMUNOHEMATOLOGY ASSAYS. THROUGH A CUSTOMER COMPLAINT INVESTIGATION, THE REACTIVITY OF ORTHOTM SERA PAPAIN OF THE AFFECTED LOTS STATED ABOVE HAS BEEN CONFIRMED AS REDUCED. BASED ON INVESTIGATION TESTING, THE CURRENT SHELF LIFE OF THE LOTS LISTED ABOVE SHOULD BE REDUCED TO PREVENT FALSE NEGATIVE REACTIONS WHEN USED IN CONJUNCTION WITH ORTHO¿ SERA RED BLOOD CELL ANTIGEN TYPING REAGENTS. THE FOLLOWING LOTS SHOULD NOW BE REMOVED FROM USE AND DISCARDED: V249596 EXP. 05 MAY 2023. V249599 EXP. 16 MAY 2023. V250681 EXP. 19 JUNE 2023. THE FOLLOWING LOTS SHOULD HAVE A NEW REDUCED EXPIRY DATE ASSIGNED AS DETAILED BELOW: V252336 EXP.10 JULY 2023. V257490 EXP. 01 AUGUST 2023. A REVIEW SHOULD BE UNDERTAKEN ON TESTING PREVIOUSLY PERFORMED WITH THE AFFECTED LOTS OF ORTHOTMSERA PAPAIN TO ENSURE ALL RESULTS RECORDED WERE AS EXPECTED AND NO UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED. THE REDUCED REACTIVITY NOTED AS AN OUTCOME OF THE INVESTIGATION IMPACTS PATIENT SAMPLES ONLY WITH EXPECTED PERFORMANCE EVIDENT USING REAGENT RED CELLS (PANEL CELLS) AND / OR RED CELL SUSPENSIONS PREPARED USING PROPRIETARY DILUENTS WHICH INCLUDE POTENTIATORS. ANY RESULTS IDENTIFIED AS ANOMALOUS SHOULD BE INVESTIGATED FURTHER WITH ORTHOTM SERA PAPAIN LOTS V252336 OR V257490. AS PER THE INSTRUCTIONS FOR USE FOR ORTHOTM SERA PAPAIN: DO NOT USE IF TURBID. ORTHOTM SERA PAPAIN IS SUPPLIED AS A CLEAR SOLUTION; ANY VIALS WHICH SHOW A STRAW COLOURED APPEARANCE SHOULD BE DISCARDED. DEVICE HAS NOT EVALUATED BY MANUFACTURER BECAUSE NOT AVAILBLE.

    Description of Event or Problem · 0

    END USER REPORTS A FALSE NEGATIVE RESULT WITH ORTHOSERA PAPAIN PRODUCT FD317 LOT V249596 EXPIRY 06MAY23. THE END USER REPORTS EIGHT DONOR SAMPLES GENERATED FALSE NEGATIVE AND WEAK POSITIVE RESULTS WITH THE REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486980 ENZYME SOLUTION PAPAIN ORTHO SERA SOLUTION, STABILIZED ENZYME, PRODUCT CODE: KSK KSK ALBA BIOSCIENCE LIMITED (LTD.) FD317 V249596 10758750030330

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown