BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPECELL-B

    MDR report key: 2823442 · Received November 8, 2012

    Report

    Report Number
    9610824-2012-00190
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    September 6, 2012
    Report Date
    January 24, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT. WE ARE STILL WAITING FOR THE PATIENT SAMPLE AND THE COMPLAINED PRODUCT. COMPLAINED PRODUCT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE PATIENT SAMPLE WITH ERYTYPECELL B ON ERYTYPE S ABD+REV. A1, B IN TANGO OPTIMO. WE ARE STILL WAITING FOR THE PATIENT SAMPLE AND THE COMPLAINED PRODUCT . SUMMARY: A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF ONE PATIENT SAMPLE WITH ERYTYPECELL B ON ERYTYPE S ABD+REV. A1, B IN TANGO OPTIMO. THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT WAS SENT TO US FOR INVESTIGATIONAL TESTING, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. AT THE TIME WE RECEIVED THE PATIENT SAMPLE THE COMPLAINED PRODUCT WAS ALREADY EXPIRED. THEREFORE TESTING OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS NOT POSSIBLE AND OUR QUALITY CONTROL TESTED THE PATIENT SAMPLE WITH THE CURRENT LOT OF ERYTYPECELL B. THE PATIENT SAMPLE REACTED NEGATIVELY. FURTHERMORE THE PATIENT SAMPLE WAS TESTED IN THE TUBE TECHNIQUE AND REACTED ONLY WITH A +/- REACTION. ONLY AFTER A PROLONGED INCUBATION IN COLD DID THE SAMPLE REACT CORRECTLY POSITIVELY AND THIS IS NOT ACCORDING THE INSTRUCTION FOR USE. THIS TESTING CONFIRMED THE WEAKNESS OF THE MISSED ISOAGGLUTININ. IT IS WELL KNOWN THAT ISOAGGLUTININS MAY BE WEAKENED OR ABSENT IN ELDERLY PATIENTS OR DURING SICKNESS. 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
    1 ERYTYPECELL-B ERYTYPECELL-B KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2233011

    Patients

    Seq Age Sex Outcome Treatment
    1 ERYTYPECELL-A1| ERYTYPECELL-A1