BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH+K TYPE

    MDR report key: 2193486 · Received July 15, 2011

    Report

    Report Number
    9610824-2011-00091
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF OUR QUALITY CONTROL LAB CONFIRMED THE CORRECT FUNCTION OF THE ERYTYPE S RH+K LOT IN QUESTION. AN INSPECTION OF THE TANGO INSTRUMENT CONFIRMED ITS CORRECT FUNCTION. THERE WERE NO INDICATIONS FOR ANY TANGO MALFUNCTIONS WHICH COULD HAVE CAUSED THE DESCRIBED ISSUE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED PRODUCT. WE HAD NO FURTHER COMPLAINTS CONCERNING FALSE POSITIVE REACTION OF CLONE (B)(4) RELATED TO THIS ERYTYPE S RH+K LOT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT A PT SAMPLE REACTED ON ERYTYPE S RH+K, (B)(4), LOT 1035010 IN THE FIRST RUN WITH ANTI-K1 (CLONE 601) WAS NEGATIVE AND WITH ANTI-K2 ((B)(4)) 2+ POSITIVE. BASED ON THE DISCREPANT RESULTS, THE CUSTOMER REPEATED THE RUN. IN THE SECOND RUN BOTH KELL CLONES REACTED NEGATIVE. THE CUSTOMER PROVIDED THREE PLATES OF THE ALLEGEDLY DEFECTIVE ERYTYPE S RH+K LOT, THE AFFECTED PT SAMPLE AND THE USED BROMELAIN FOR INVESTIGATION TESTING. THE PT SAMPLE WAS TESTED WITH THE BROMELAIN SAMPLE FROM THE CUSTOMER AND ADDITIONALLY WITH THE RETENTION SAMPLE OF OUR QC LAB. IN ALL RUNS, BOTH KELL CLONES REACTED NEGATIVELY. AS EXPECTED, THE CONTROL SAMPLES ALSO REACTED UNAMBIGUOUSLY CORRECTLY POSITIVE RESPECTIVELY CORRECTLY NEGATIVE. FURTHERMORE, THE PROVIDED ALLEGEDLY DEFECTIVE SAMPLE OF ERYTYPE S RH+K WAS TESTED WITH 13 KELL NEGATIVE DONOR SAMPLES FROM OUR BLOOD BANK. IN ALL CASES, THE KELL CLONES REACTED CORRECTLY NEGATIVE. THUS WE CANNOT CONFIRM THE INITIAL FALSE POSITIVE REACTION OF ANTI-KELL ((B)(4)) AT THE CUSTOMER'S SITE.

    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 MEDICAL DIAGNOSTICS GMBH 1035010

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO: SERIAL NO (B)(4)