BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH+K TYPE

    MDR report key: 5366098 · Received January 14, 2016

    Report

    Report Number
    9610824-2016-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 16, 2015
    Report Date
    February 25, 2016
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT SAMPLE SHOWED A FALSE POSITIVE REACTION WITH ANTI-K WHEN TESTED ON ERYTYPE S RH+K TYPE IN TANGO OPTIMO. THE CUSTOMER REPORTED THAT THE PATIENT SAMPLE SHOWED A POSITIVE DIRECT ANTIGLOBULIN TEST (DAT) BUT THE CUSTOMER DID NOT REPORT THE CAUSE OF THE POSITIVE DAT, E.G. AUTOANTIBODY OR COLD ANTIBODY. THE CUSTOMER DID NEITHER RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE RESULT NOR THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT WITH DIFFERENT SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTION. THE INSTRUCTION FOR USE CONTAINS A NOTE IN THE SECTION LIMITATIONS THAT AUTOANTIBODIES, COLD ANTIBODIES AND ANTIBODIES TO ANTIBIOTICS OR OTHER REAGENTS MAY CAUSE FALSE POSITIVE RESULTS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE S RH+K TYPE FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS INSPECTED BY ONE OF OUR FIELD SERVICE ENGINEERS. THE FILES WERE ANALYZED SEVERAL TIMES NAME AND NUMBER ("LAVALLEE BB, MOTHER IS (B)(6) AND THE NUMBER IS (B)(6)") THE CUSTOMER STATED IN THIS COMPLAINT COULD NOT BE FOUND, NEITHER IN THE LAB JOURNAL NOR IN THE DAILY JOURNAL. WE HAVE NO INSTIGATION FOR A MALFUNCTION OF THE AFFECTED INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT SAMPLE YIELDED A FALSE POSITIVE REACTION WITH ANTI-K WHEN TESTED ON ERYTYPE S RH+K TYPE IN TANGO OPTIMO. THE CUSTOMER ADVISED TO SEND A PATIENT SAMPLE AS WELL AS THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. WE ARE STILL WAITING FOR THESE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27460 ERYTYPE S RH+K TYPE ERYTYPE S RH+K TYPE KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8530070

    Patients

    Seq Age Sex Outcome Treatment
    1