A COMPLAINT WAS RECEIVED THAT INDICATED THE CUSTOMER WAS EXPERIENCING QC FAILURES WHEN PROCESSING PT SAMPLES ON A GENPROBE 100/4 DTS LIQUID HANDLING INSTRUMENT. THE CUSTOMER WAS PROCESSING PT SAMPLES USING A GENPROBE STREP A KIT. THE QC FAILED ON A RUN AND LABORATORY REPEATED THE RUN AND IT PASSED SUCCESSFULLY. THE LABORATORY RELEASED RESULTS TO PHYSICIANS. THE NEXT DAY, THE LABORATORY OBSERVED THAT THE REAGENT RESERVOIR WAS DRY. THE INSTRUMENT HAS A FEATURE TO DETECT THE LIQUID LEVEL IN THE RESERVOIR AND SEND AN ERROR MESSAGE TO ALERT THE OPERATOR THAT NOT ENOUGH LIQUID IS PRESENT. THE OPERATOR DID NOT RECEIVE AN ERROR MESSAGE. THE LABORATORY RERAN PT SAMPLES MANUALLY AND RE-REPORTED RESULTS. TO THEIR KNOWLEDGE, NO INCORRECT TEST RESULTS HAVE BEEN RELEASED TO PHYSICIANS. THE INSTRUMENT WAS REMOVED FROM SERVICE AND A REQUEST FOR FIELD SERVICE TO INVESTIGATE THE CAUSE OF THE LIQUID LEVEL DETECT ERROR FUNCTION WAS INITIATED.
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Patient 1
A FIELD SERVICE REPRESENTATIVE EVALUATED THE INSTRUMENT AT THE CUSTOMER'S LABORATORY ON (B)(4) 2013. THE PARTS ASSOCIATED WITH THE LIQUID LEVEL DETECTION FEATURE WERE REPLACED AND THE INSTRUMENT PASSED REQUIRED DIAGNOSTIC TEST AND WAS RETURNED TO SERVICE. THE PARTS REMOVED FROM THE INSTRUMENT WERE RETURNED TO MANUFACTURER FOR EVALUATION. THE PARTS WERE DETERMINED TO BE OUT OF WARRANTY. THE EXPECTED LIFETIME IS 2 YEARS AND THE PARTS WERE DATED 2009-WEEK 04 OR JANUARY 2009. MANUFACTURER PREVENTIVE MAINTENANCE DIRECTIONS REQUIRE THAT THE PARTS ARE REPLACED WHEN PERFORMING AN ANNUAL PM. THE LAST ANNUAL PM WAS NOVEMBER 2011 AND THE PARTS HAD NOT BEEN REPLACED AS REQUIRED. A CAPA HAS BEEN OPENED TO INVESTIGATE THE ROOT CAUSE OF THE FAILURE TO REPLACE PARTS AS PER THE PREVENTIVE MAINTENANCE SERVICE DIRECTIONS.