BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-K (KEL2)

    MDR report key: 2527081 · Received March 18, 2010

    Report

    Report Number
    9610824-2010-00004
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 17, 2010
    Manufacturer
    BIOTEST MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SAFETY CORRECTIVE ACTION WAS INITIATED (NOT IN THE U.S.). THE AFFECTED BATCHES ARE NOT ON THE U.S. MARKET, AS THE MENTIONED CATALOG NUMBER IS USED FOR NON-US-PRODUCT ONLY. STN#: 125232.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT THREE PATIENTS WERE TYPED FALSE POSITIVE USING THE BLOOD GROUPING REAGENT SERACLONE ANTI-K (KEL2). THE CUSTOMER SENT US TWO OF THREE PATIENT SAMPLES. THESE PATIENT SAMPLES WERE TESTED WITH THE RETENTION SAMPLE OF THE COMPLAINED LOT IN THE QUALITY CONTROL LABORATORY ACCORDING TO THE INSTRUCTIONS FOR USE. WE CONFIRMED THE FALSE POSITIVE REACTIONS OF THE CUSTOMER. THE CUSTOMER WAS AWARE OF THE FALSE POSITIVE REACTIONS BECAUSE HE TESTED THE SAMPLES WITH TWO DIFFERENT ANTI-K (KEL2) REAGENTS ACCORDING TO THE (B)(6) RULES "(B)(4)." THE AFFECTED LOT (B)(4) WAS FILLED OF THE BULK LOT 84707. A SECOND LOT, THE LOT (B)(4), WAS ALSO FILLED OF THE BULK LOT (B)(4). ALTHOUGH WE DID NOT RECEIVE ANY COMPLAINT FOR LOT (B)(4), THE BATCH WAS TESTED AND REACTED ALSO FALSE POSITIVE. ALBA BIOSCIENCE LIMITED, THE SUPPLIER OF THE BULK REAGENT SERACLONE ANTI-K (KEL2) WAS INFORMED AND CONFIRMED THE FALSE POSITIVE REACTIONS. AS A CONSEQUENCE OF THE CONFIRMED FALSE POSITIVE REACTIONS BOTH LOTS (B)(4) WERE BLOCKED AND A FIELD SAFETY CORRECTIVE ACTION WAS INITIATED. THE AFFECTED BATCHES ARE NOT ON THE U.S MARKET, AS THE MENTIONED CATALOG NUMBER IS USED FOR NON-US-PRODUCT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERACLONE ANTI-K (KEL2) SERACLONE KSZ BIOTEST MEDICAL DIAGNOSTICS GMBH 1847071

    Patients

    Seq Age Sex Outcome Treatment
    1