BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMARKERS

    MDR report key: 827419 · Received February 23, 2007

    Report

    Report Number
    2953151-2007-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2007
    Report Date
    February 15, 2007
    Manufacturer
    LAB VISION CORP.
    Product Code
    MXZ
    PMA / PMN Number
    K060462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THE COMPLAINT OF FALSE POSITIVE STAINING HAS BEEN RAISED, NO DEATH AND ADVERSE EVENT HAS BEEN REPORTED. HOWEVER, IN THE INTEREST OF ENSURING USER SAFETY AND WELFARE, SINCE DECEMBER 2006 COMPANY DECIDED TO PUT SP2 PRODUCTS ON HOLD (STOP SELLING AND STOP SHIPMENT), AND AN ADVISORY NOTICE WAS ISSUED AND DISTRIBUTED TO RECIPIENTS OF EARLIER SHIPMENTS. THE ADVISORY NOTICE HAS ALSO BEEN POSTED ON COMPANY'S WEBSITE. TO INVESTIGATE THE ROOT CAUSE OF THE SUSPECTED FALSE POSITIVE STAINING PROBLEM ASSOCIATED WITH 9102S509 LOT, WE HAVE CONTACTED THE RAW MATERIAL SUPPLIER OF SP2, SPRING BIOSCIENCE. WE FOUND THE SUPPLIER CHANGED THE RAW MATERIAL OF 9102S509 LOT WITHOUT INFORMING US THE CHANGE. THE FALSE POSITIVE STAINING PROBLEM MAY COME FROM THE CHANGE OF RAW MATERIAL. WE WILL FURTHER INVESTIGATE THE ROOT CAUSE OF THE FALSE POSITIVE ISSUE AND FILE SUPPLEMENTAL REPORT LATER. IN ADDITION, COMPANY HAS STARTED ANOTHER STUDY TO COMPARE THE BEHAVIOR OF THE CURRENT BATCH OF SP2 AND A PREDICATE DEVICE. WE EXPECT TO HAVE THE RESULT IN MID MARCH 2007 AND WILL FILE A SUPPLEMENTAL REPORT TO FDA IF ADD'L INFO BECOMES AVAILABLE. IN THE MEANTIME, WE CONTINUE TO HOLD AND NOT SELL THE SP2 PRODUCT.

    Description of Event or Problem · 1

    A COMPLAINT WAS RAISED BY COMPANY'S MARKETING MGR REGARDING CATALOG #RM-9102, NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR (PR) ANTIBODY, CLONE SP2 (SP2). THE COMPLAINT REPORTED THE OBSERVATION OF FALSE POSITIVE STAINING WITH SP2, WHEN COMPARED TO ANOTHER COMMERCIALLY AVAILABLE PR ANTIBODY. ALTHOUGH, THE COMPLAINT OF FALSE POSITIVE STAINING HAS BEEN RAISED, NO DEATH AND ADVERSE EVENT HAVE BEEN REPORTED. OUR INVESTIGATION OF 4 BATCHES REASONABLY CONFIRMED THE FALSE POSITIVE STAINING PROBLEM OF ONE SPECIFIC BATCH, LOT# 9102S509, OF SP2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMARKERS RABBIT MONOCLONAL ANTI-PR, CLONE SP2 MXZ LAB VISION CORP. NA 9102S509

    Patients

    Seq Age Sex Outcome Treatment
    1 *