BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH+K TYPE

    MDR report key: 1983117 · Received January 17, 2011

    Report

    Report Number
    9610824-2011-00006
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 18, 2010
    Report Date
    January 19, 2011
    Manufacturer
    BIO-RAD MED DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PT SAMPLE WITH ANTI-C ERYTYPE S RH + K TYPE ART # 806195100, LOT 7030010. THE CUSTOMER HAD SENT US THE PT SAMPLE AND THE COMPLAINED PRODUCT. BOTH WERE TESTED ON TANGO IN THE QUALITY CONTROL LABORATORY. THE TESTING RESULTED IN A CLEAR AND STRONG POSITIVE REACTION WITH ANTI-C ON ERYTYPE S RH + K TYPE. ADDITIONALLY, THERE WERE TESTED FURTHER CONTROLS ON ERYTYPE S RH + K TYPE: ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT AND CLEAR WITHOUT ANY AMBIGUITY. INSPITE OF OUR TEST RESULTS, THE PT SAMPLE WILL BE SENT FOR MOLECULAR TYPING OF THE RHESUS PHENOTYPE TO AN EXTERNAL LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERYTYPE S RH+K TYPE ERYTYPE S RH+K TYPE KSZ BIO-RAD MED DIAGNOSTICS GMBH 7030010

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO, SERIAL # (B)(4)| IMMUCOR ANTI-C LOT 936030 EXP. 02/13/2012| BROMELIN LOT 7035070 EXP 02/26/2011