BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH PHENO DOUBLE

    MDR report key: 2101901 · Received May 3, 2011

    Report

    Report Number
    9610824-2011-00053
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A PATIENT SAMPLE WITH ANTI-E ON ERYTYPE S RH PHENO DOUBLE ART - # (B)(4), LOT 1032030. CUSTOMER HAD SENT US THE PATIENT SAMPLE BUT NOT THE COMPLAINED PRODUCT. THE SAMPLE WAS TESTED ON THE RETENTION SAMPLE OF THE COMPLAINED LOT ON TANGO IN QUALITY CONTROL LABORATORY. THE SAMPLE REACTED NEGATIVELY WITH ANTI-E ON ERYTYPE S RH PHENO DOUBLE. FURTHERMORE, DIFFERENT CONTROLS WERE TESTED ON ERYTYPE S RH PHENO DOUBLE: ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT AND CLEAR WITHOUT ANY AMBIGUITY. ADDITIONALLY, THE PATIENT SAMPLE WAS TESTED WITH DIFFERENT ANTI-E REAGENTS OF COMPETITORS IN THE TUBE TECHNIQUE AT DIFFERENT INCUBATION TEMPERATURE AND TIMES. THE SAMPLE SHOWED REACTIONS FROM NEGATIVE TO POSITIVE. THEREFORE WE HAVE THE EDUCATED GUESS OF A VARIANT OR A WEAKENED EXPRESSION OF E ANTIGEN. SAMPLE WAS SENT FOR MOLECULAR TYPING OF THE RHESUS PHENOTYPE TO AN EXTERNAL LABORATORY. WE ARE STILL WAITING FOR THE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERYTYPE S RH PHENO DOUBLE ERYTYPE S RH PHENO DOUBLE KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 1032030

    Patients

    Seq Age Sex Outcome Treatment
    1 SCAN GEL MONICLONAL RH/K PHENOTYPES: LOT 00190.02| TANGO OPTIMO: SERIAL # (B)(4)