BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BGR, ANTI-D (MONOCLONAL) (IGG BLEND)

    MDR report key: 2070560 · Received March 30, 2011

    Report

    Report Number
    9610824-2011-00035
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    125218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE REACTION WITH SOLIDSCREEN II ANTI-D BLEND. THE CUSTOMER COULD SEND US NEITHER THE SAMPLE NOR THE COMPLAINED PRODUCT. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINED LOT WITH DIFFERENT WEAK D POSITIVE AND RH(D) NEGATIVE SAMPLES. ALL REACTIONS WERE CORRECTLY POSITIVE RESPECTIVELY "NEGATIVE." WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. DUE TO THE DOCUMENTED TEST RESULT (PHOTO) OF THE CUSTOMER, WE PRESUME A HANDLING FAILURE OF THIS CUSTOMER. TESTING OF OUR QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE AFFECTED SOLIDSCREEN II ANTI-D BLEND LOT. A REVIEW OF THE BATCH RECORD DOCUMENTATION GIVES NO HINTS TO ANY IRREGULARITIES WHICH MIGHT HAVE AFFECTED THE QUALITY OF THE COMPLAINED LOT NEGATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BGR, ANTI-D (MONOCLONAL) (IGG BLEND) SOLIDSCREEN II ANTI-D (RH1) BLEND KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7019060-01

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL 3: LOT 8103011, EXP. 03/08/2011| ERYTYPE S ABD+REV.A1, B: LOT 7043030| TANGO: SERIAL NO. (B)(4)| MLB2: LOT 7013110, EXP. 03/19/2012| ERYTYPECELL A1 AND B: LOT 8103011, EXP. 03/15/2011| AHG, ANTI-IGG SOLIDSCREEN: LOT 7016110-03| BROMELIN FOR ERYTYPE: LOT 7035070, EXP. 02/26/2011| EXP. 04/22/2012| EXP. 10/12/2011| ALSEVERS SOLUTION: LOT 7008022, EXP. 11/05/2011| SOLIDSCREEN II STRIP: LOT 7023020, EXP. 06/03/2012| SOLIDSCREEN II PLATES: (B)(4)