BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S ABD REV. A1&B

    MDR report key: 2594434 · Received November 25, 2010

    Report

    Report Number
    9610824-2010-00014
    Event Type
    Malfunction
    Date Received
    November 25, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 25, 2010
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    125094-97
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF ERYTYPE S ABD+REV.1A,B ART.-NO. (B)(4), LOT 7925020. THE CORRECT FUNCTION OF ERYTYPE WAS CONFIRMED UNTIL EXPIRY DATE BY THE STABILITY STUDIES. THE TWO SAMPLES OF CUSTOMER REACTED POSITIVE, EVEN THOUGH THE TWO SAMPLES WERE TYPE AS WEAK D AND THERE IS A HINT IN THE INSTRUCTION FOR USE THAT SAMPLES WITH WEAKENED D ANTIGENS WILL GIVE WEAKENED OR NEGATIVE REACTIONS WITH THE ANTI-D REAGENTS. WE HAD NO FURTHER COMPLAINTS RELATING TO THIS PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RAN A SAMPLE ON TANGO AND RECEIVED A NEGATIVE RESULT WITH THE ANTI-D REAGENTS ON ERYTYPE S ABD+REV. A1,B ART. -NO. (B)(4), LOT 7925020, BUT DUE TO A FORMER RESULT THE RH (D) TYPE OF THE SAMPLE WAS DOCUMENTED AS RH (D) POSITIVE. THEREFORE CUSTOMER ASKED FOR A REDRAW. THEN CUSTOMER RAN THE OLD AND THE REDRAWN SAMPLE AGAIN ON TANGO. THE CUSTOMER USED ANOTHER LOT OF ERYTYPE S ABD+REV. A1, B FOR THIS SECOND TESTING. NOW THE CUSTOMER GOT 2+ POSITIVE REACTIONS WITH BOTH ANTI-D REAGENTS ON THE ERYTYPE S ABD+REV. A1, B. THE CUSTOMER SENT US THE INITIALLY DRAWN, THE REDRAWN BLOOD SAMPLE AND SAMPLES OF THE COMPLAINED ERYTYPE S ABD +REV. A1, B ART. -NO. (B)(4), LOT 7925020. THE TWO BLOOD SAMPLES WERE TESTED ON THE COMPLAINED LOT OF ERYTYPE IN THE QUALITY CONTROL LABORATORY. BOTH SAMPLES REACTED CLEARLY POSITIVE (1+ POSITIVE) WITH THE ANTI-D REAGENTS OF ERYTYPE ON TANGO. FURTHERMORE WE SENT THE TWO SAMPLES FOR MOLECULAR TYPING OF THE RH (D) TYPE TO AN EXTERNAL LABORATORY. THE RESULT OF THIS EXTERNAL INVESTIGATION IS THAT BOTH SAMPLES ARE WEAK D TYPE 4.2.3. THERE IS A HINT IN THE INSTRUCTION FOR USE THAT CATEGORY VII AND VERY WEAK EXPRESSIONS OF THE D ANTIGEN WILL GIVE WEAKENED OR NEGATIVE REACTIONS WITH THE ANTI-D REAGENTS ON THIS STRIP. IN THIS SPECIAL CASE THE CONFIRMED WEAK D SAMPLES REACTED POSITIVE ON THE COMPLAINED ERYTYPE PLATE. THEREFORE WE CANNOT CONFIRM THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERYTYPE S ABD REV. A1&B ERYTYPE S ABD REV. A1&B KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7925020

    Patients

    Seq Age Sex Outcome Treatment
    1 BROMELIN: LOT 7024151 (EXP. ?)| ERYTYPE A1&B CELLS: LOT 7039011 (EXP. ?)| NEW LOT ERYTYPE PLATES: (B)(4) (EXP. 02/07/2011)