BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-K (KEL1)

    MDR report key: 2254818 · Received August 23, 2011

    Report

    Report Number
    9610824-2011-00113
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STN# 125230.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE REACTIONS OF SERACLONE ANTI-K WITH A KELL HETEROZYGOUS CELL FROM REAGENT RED BLOOD CELLS OF A COMPETITOR. THE CUSTOMER HAD SENT US THE ALLEGEDLY DEFECTIVE SAMPLE AND THE AFFECTED COMPETITOR'S REAGENT RED BLOOD CELLS. BOTH WERE RESTED AND REACTED CORRECTLY POSITIVE. THE ALLEGEDLY DEFECTIVE SAMPLE WAS TESTED WITH FURTHER K+K+ RED CELLS OF DONORS AND COMMERCIALLY AVAILABLE PANEL CELLS. ALL POSITIVE REACTIONS WERE CORRECT AND UNAMBIGUOUS POSITIVE. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING OF OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE AFFECTED LOT OF SERACLONE ANTI-K. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERACLONE ANTI-K (KEL1) SERACLONE ANTI-K LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7007130-01

    Patients

    Seq Age Sex Outcome Treatment
    1 IMMUCOR PANEL 16: LOT# 24019, EXP: 08/19/2011| IMMUCOR PANEL 16: LOT# 22993, EXP: 08/05/2011