Description of Event or Problem · 1
BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CALL IN 2007 FROM MEDICAL CENTER. THE CUSTOMER REPORTED THAT ON THE MONTH BEFORE, THEY WERE RUNNING THREE DIAGNOSTIC ASSAYS: ORTHO HCV 3.0, BIO-RAD GENETIC SYSTEMS HBSAG 3.0, AND BIO-RAD GENETIC SYSTEMS HIV-1/HIV-2 PLUS O USING THE FOUR-PLATE MICROWELL PLATE PROCESSING SYSTEM CALLED THE EVOLIS. AFTER THE ORTHO HCV 3.0 AND BIO-RAD GENETIC SYSTEMS HBSAG 3.0 PLATES WERE PIPETTED THE TECHNICIAN REMOVED THE PATIENT SAMPLE, CONTROL AND REAGENT RACKS FOR ALL THREE ASSAYS. WHEN THE BIO-RAD GENETIC SYSTEMS HIV-1/HIV-2 PLUS O CONTROLS BEGAN TO DISPENSE, AN ALARM WENT OFF TO NOTIFY THE TECHNICIAN THAT SOME MATERIALS NEEDED TO PROCESS THE ASSAYS WERE NOT PRESENT ON THE MICROPLATE PROCESSOR. IN RESPONSE TO THE ALARM, THE TECHNICIAN REPLACED THE CONTROL AND REAGENT RACK FOR THE BIO-RAD GENETIC SYSTEMS HIV-1/HIV-2 PLUS O, BUT DID NOT REPLACE THE PATIENT SAMPLE RACK. THE TECHNICIAN PROCEEDED TO COMPLETE THE ASSAY RUN EVEN THOUGH NO PATIENT SAMPLES HAD BEEN PIPETTED ONTO THE MICROWELL PLATE. BIO-RAD TECHNICAL SUPPORT REQUESTED THE SITE FAX THE RUN DATA AND EVENT LOG DATED THE SAME MONTH FOR REVIEW. A REVIEW OF THE INFORMATION, INCLUDED ON THE REPORT, SHOWED THAT ALL WELLS OF THE PLATE RUN FOR THE BIO-RAD GENETIC SYSTEMS HIV-1/HIV-2 PLUS O WERE FLAGGED WITH THE ERROR "NOLIQ, SPLREM, VDFAIL" WHICH STANDS FOR NO LIQUID, SAMPLE REMOVED AND VERIFY DISPENSE FAILURE. THERE WERE NO ERRORS REPORTED ON THE OTHER TWO ASSAYS. THE EVOLIS IS A PASSWORD PROTECTED SYSTEM, WITH SPECIFIC CONTROLS IN PLACE THAT ALLOW ONLY AUTHORIZED PERSONNEL TO OVERRIDE THESE PARTICULAR ERROR FLAGS. IN THIS INSTANCE, THE SUPERVISOR HAD THE NECESSARY AUTHORIZATION TO OVERRIDE THE SYSTEM, AND DESPITE THE ERROR FLAG THE SUPERVISOR PROCEEDED TO OVERRIDE THE ORIGINAL REPORTED RESULTS OF "NO RESULT". THE SUPERVISOR STATED THAT THE REASON THEY DECIDED TO OVERRIDE THE ERROR FLAG WAS BECAUSE THE TECHNICIAN, RUNNING THE ASSAY, HAD INFORMED HER THAT THE PATIENT SAMPLE RACK WAS ON THE EVOLIS DURING THE RUN. THE REPORT GENERATED AFTER THE CUSTOMER OVERRODE THE ORIGINAL ERROR FLAGS INDICATED ALL 41 PATIENT SAMPLES ON THE PLATE WERE NON-REACTIVE FOR HIV-1/HIV-2. WHEN THE SUPERVISOR RECOGNIZED THAT THE PATIENT SAMPLE RACK HAD NOT BEEN PRESENT AND THAT THE INITIAL ERROR FLAGS SHOULD NOT HAVE BEEN OVERRIDDEN, THE TECHNICIAN REPEATED THE TESTING ON THE 41 PATIENT SAMPLES. THE RESULTS OF RETESTING SHOWED THAT ONE OF THE 41 SAMPLES PRODUCED A REACTIVE RESULT. THE SINGLE NON-REACTIVE REPORT WAS CORRECTED AND THE TREATING PHYSICIAN WAS IMMEDIATELY NOTIFIED. THE CUSTOMER PERFORMED A SUPPLEMENTAL CONFIRMATORY TEST HIV-1 TEST ON THE ONE REACTIVE SAMPLE AND THE SAMPLE WAS POSITIVE.