BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH+K

    MDR report key: 2942944 · Received February 5, 2013

    Report

    Report Number
    9610824-2013-00004
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    June 30, 2012
    Report Date
    February 5, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DISCREPANT RESULTS OF ONE PATIENT SAMPLE WHEN TESTED WITH ERYTYPE S RH+K. THE CUSTOMER REPORTED THAT THE SAMPLE REACTED NEGATIVELY WITH ANTI-C ON ERYTYPE ON THE STATED DATE OF EVENT AND ALSO WHEN RE-TESTED TWO DAYS LATER, ON (B)(6) 2012. WHEN A SECOND SAMPLE OF THAT SAME PATIENT WAS RETESTED ON (B)(6) 2012, IT YIELDED A POSITIVE RESULT WITH ANTI-C. THE CUSTOMER HAS NEITHER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT. AT THE TIME THE CUSTOMER FILED THIS COMPLAINT, THE SUPPOSEDLY DEFECTIVE PRODUCT HAD ALREADY BEEN EXPIRED. THEREFORE A TESTING OF THE RETAINED ERYTYPE S RH+K SAMPLE IN OUR QUALITY CONTROL LABORATORY WAS NOT POSSIBLE. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. WE DID NOT RECEIVE ANY FURTHER COMPLAINTS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48636 ERYTYPE S RH+K ERYTYPE S RH+K KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2118010

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO OPTIMO, # 9142400320| TANGO OPTIMO, # 9142400362