BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-A,B

    MDR report key: 2988791 · Received March 5, 2013

    Report

    Report Number
    9610824-2013-00018
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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 THE SERACLONE ANTI-A, B REAGENT IS CLOUDY AND THE POSITIVE AND NEGATIVE CONTROLS WOULD NOT WORK PROPERLY. THE CUSTOMER HAS RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT, BUT NONE OF THE POSITIVE AND NEGATIVE CONTROLS THAT SEEMINGLY DID NOT WORK PROPERLY. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE OF SERACLONE ANTI-A, B WITH DIFFERENT RED CELLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE OR FALSE POSITIVE REACTIONS. THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALSO SENT TO AN EXTERNAL LABORATORY FOR MICROBIOLOGICAL GROWTH. WE ARE STILL WAITING FOR THIS RESULT. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-A, B FUNCTIONS CORRECTLY. 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 THAT THE SERACLONE ANTI-A,B REAGENT IS CLOUDY AND THE POSITIVE AND NEGATIVE CONTROLS WOULD NOT WORK PROPERLY. THE CUSTOMER HAS RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT, BUT NONE OF THE POSITIVE AND NEGATIVE CONTROLS THAT SEEMINGLY DID NOT WORK PROPERLY. OUR QUALITY CONTROL LABORATORY TESTED THE COMPLAINT SAMPLE OF SERACLONE ANTI-A,B WITH DIFFERENT RED CELLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE OR FALSE POSITIVE REACTIONS. THE SUPPOSEDLY DEFECTIVE PRODUCT AND THE RETAINED SAMPLE OF SERACLONE ANTI-A,B WERE SENT TO AN EXTERNAL LABORATORY FOR MICROBIOLOGICAL GROWTH. THE COMPLAINT SAMPLE WAS CLOUDY, WHILE OUR QUALITY CONTROL LABORATORY'S RETAINED SAMPLE WAS CLEAR. THE EXTERNAL LABORATORY FOUND ONE SINGLE GERM IN THE COMPLAINT SAMPLE AND ONE SINGLE GERM IN THE RETAINED SAMPLE. SINCE THE RETAINED SAMPLE IS CLEAR DESPITE THE SINGLE GERM, THE SINGLE GERM CAN NOT BE CAUSATIVE FOR THE CLOUDINESS OF THE CUSTOMER'S SAMPLE. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF SERACLONE ANTI-AB 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
    94608 BLOOD GROUPING REAGENT ANTI-A,B SERACLONE ANTI-A,B KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8132060-02

    Patients

    Seq Age Sex Outcome Treatment
    1