FLEX MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR CLONE EP1

Description of Event or Problem

THE CUSTOMER REPORTED THAT SEVERAL BREAST CORE BIOPSY CASES DEMONSTRATED EXCESSIVE STRONG POSITIVE TUMOR CELLS WITH SIGNIFICANT BACKGROUND AND CYTOPLASMIC STAINING MAKING ONE CASE UNINTERPRETABLE AND UNREPORTABLE DESPITE ACCEPTABLE CONTROLS. THE ISSUE WAS SUSPECTED TO BE RELATED TO UNIDENTIFIED PRE ANALYTICAL/SAMPLE HANDLING FACTORS RATHER THAN A CONFIRMED DEVICE/REAGENT MALFUNCTION. ONE PATIENT UNDERWENT A REPEAT BIOPSY ON (B)(6) 2026 BECAUSE ESTROGEN RECEPTOR STATUS COULD NOT BE RELIABLY DETERMINED FROM THE ORIGINAL SAMPLE. THE REPEAT BIOPSY SHOWED SIMILAR STAINING RESULTS. THE SAMPLE WAS LATER TESTED AT ANOTHER LABORATORY USING AN ALTERNATIVE INSTRUMENT AND CLONE, WHICH PRODUCED A REPORTABLE RESULT. AGILENT'S INVESTIGATION DID NOT IDENTIFY A DEFINITIVE DEVICE MALFUNCTION OR ROOT CAUSE. BASED ON REPORTED INFORMATION, THE INVESTIGATION CONCLUDED THAT THE EVENT WAS MOST LIKELY ASSOCIATED WITH PRE ANALYTICAL FACTORS RATHER THAN CONFIRMED DEVICE FAILURE. THE RESULTS WILL CONTINUE TO BE MONITORED, AND AGILENT WILL BE NOTIFIED IF THE ISSUE RECURS. THERE WERE NO CONCERNS OF INCORRECT RESULTS BEING RELEASED TO THE PATIENT. HOWEVER, THE AFFECTED PATIENT UNDERWENT AN ADDITIONAL RE BIOPSY PROCEDURE DUE TO LACK OF SUFFICIENT SAMPLE DRAW IN FIRST BIOPSY.

Additional Manufacturer Narrative

THE INVESTIGATION COULD NOT IDENTIFY A CONFIRMED DEVICE MALFUNCTION, REAGENT DEFECT, OR INSTRUMENT FAILURE. BASED ON THE AVAILABLE INFORMATION, THE ISSUE WAS CONSIDERED MOST LIKELY RELATED TO UNKNOWN PRE-ANALYTICAL/SAMPLE HANDLING FACTORS AFFECTING SPECIFIC BREAST CORE BIOPSY SPECIMENS. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THE AFFECTED SAMPLE WAS TESTED AT ANOTHER LABORATORY USING AN ALTERNATIVE INSTRUMENT AND CLONE, WHERE AN INTERPRETABLE RESULT WAS OBTAINED. THE INVESTIGATION WAS COMPLETED AND THE CUSTOMER CONTINUED USE OF AGILENT DEVICE.