BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH-PHENO DOUBLE

    MDR report key: 4120334 · Received September 26, 2014

    Report

    Report Number
    9610824-2014-00065
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO PATIENT SAMPLES YIELDED CORRECT NEGATIVE REACTIONS WITH ANTI-E (CLONE 906) BUT FALSE POSITIVE REACTIONS WITH ANTI-E (CLONE MS260/MS12) ON ERYTYPE S RH-PHENO DOUBLE. THE CUSTOMER DID RETURN ONE PATIENT SAMPLE THAT HAD CAUSED THE DISCREPANT RESULT, BUT THE SUPPOSEDLY DEFECTIVE PRODUCT WAS NOT SEND FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE AND ADDITIONAL DONOR SAMPLES ON THE RETAINED ERYTYPE S RH-PHENO SAMPLE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED: THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH-PHENO DOUBLE FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601689 ERYTYPE S RH-PHENO DOUBLE ERYTYPE S RH-PHENO DOUBLE KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2402120

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO INFINITY, # (B)(4)