Description of Event or Problem · 0
ON 27FEB2022, GRIFOLS RECEIVED NOTIFICATION THAT THE CUSTOMER, CREATIVE TESTING SOLUTIONS (USA), REPORTED LOWER THAN EXPECTED PARASITE TRANSPORT MEDIUM (PTM) VOLUME HAD BEEN ASPIRATED INTO PREFILL LYSATE TUBES WHEN PREPARING LYSATE SPECIMENS ON THE PROCLEIX XPRESS SYSTEM FOR FURTHER PROCESSING WITH THE PROCLEIX BABESIA ASSAY ON THE PROCLEIX PANTHER SYSTEM. GRIFOLS TECHNICAL ACCOUNT SPECIALIST ONSITE OBSERVED PREFILL RUN AND NOTED THAT TIPS WERE NOT SUBMERGED IN THE PTM DURING ASPIRATION, LEADING TO THE ASPIRATION OF AIR AND NOT DISPENSING PTM INTO THE PREFILL TUBES. THIS WAS DETERMINED TO BE DUE TO FAILED LIQUID LEVEL DETECTION (LLD). THIS COMPLAINT DOES NOT INVOLVE INJURY, DAMAGE OR MEDICAL INTERVENTION DUE TO MALFUNCTION, SINCE THE CUSTOMER ONLY RELEASED THE RETEST RESULTS (WHICH WERE NOT QUESTIONABLE) TO THE CLIENT. AFTER THE LLD/PMP MODULE AND DITI CONE WERE REPLACED, THE INSTRUMENT PASSED ALL TESTS IN THE SERVICE SOFTWARE. THIS INDICATED THAT HARDWARE FAILURE, LIKELY A FAULTY LLD/PMP MODULE IS THE CAUSE OF THE FALSE LIQUID LEVEL DETECTION, AND THE ISSUE IS ISOLATED TO ONE XPRESS INSTRUMENT. WITH LOWER THAN EXPECTED PTM IN THE PREFILL TUBE, CELL LYSIS FOR RELEASE OF PARASITIC RNA FROM THE SPECIMEN FOR FURTHER DETECTION BY THE ASSAY COULD BE IMPACTED POTENTIALLY RESULTING IN A FALSE NEGATIVE RESULT. ALTHOUGH A STUDY COMPLETED BY GRIFOLS R&D DETERMINED THAT THERE IS NO IMPACT TO RESULTS WHEN THE SAMPLE TO PTM VOLUME RATIO IS 1:2 INSTEAD OF THE STANDARD 1:3, THE ACTUAL VOLUME PIPETTED AT THE CUSTOMER SITE COULD NOT BE CONFIRMED. GRIFOLS DETERMINED THAT THE WORST-CASE SCENARIO FOR THIS EVENT COULD BE AN INCORRECT RESULT (I.E. FALSE NEGATIVE RESULT), WHICH GIVES A SEVERITY RATING OF CRITICAL. A SEARCH FOR PREVIOUS EVENTS IN GRIFOLS COMPLAINT RECORDS FOR A PERIOD GOING BACK ONE YEAR FROM THE DATE OF INCIDENT THROUGH THE PRESENT DATE ((B)(6) 2021 TO (B)(6) 2022) WAS EXECUTED. THERE HAVE BEEN 3 OTHER COMPLAINTS FILED FOR PTM PIPETTING ISSUES. HOWEVER, NONE OF THE 3 COMPLAINTS WERE RELATED TO LOWER THAN EXPECTED PTM VOLUME IN PREFILL TUBES. AS A RESULT, THE PROBABILITY IS DETERMINED TO BE REMOTE BASED ON PREVIOUS EVENTS SEARCH RESULT AND THE FACT THAT THE ISSUE IS ISOLATED TO ONE XPRESS INSTRUMENT DUE TO FAULTY COMPONENT. FOLLOWING ISO 14971, GRIFOLS RISK ASSESSMENT IS BASED ON SEVERITY OF HARM OR IMPACT TO HUMAN HEALTH AND THE PROBABILITY OF OCCURRENCE OF HARM OR IMPACT TO HUMAN HEALTH. GRIFOLS DETERMINED THAT THE WORST-CASE SCENARIO FOR THIS EVENT COULD BE AN INCORRECT RESULT (I.E. FALSE NEGATIVE RESULT), WHICH GIVES A SEVERITY RATING OF CRITICAL. THE PROBABILITY OF THIS QUALITY DEFECT OCCURRING IS ASSESSED AS REMOTE BASED ON PREVIOUS EVENTS SEARCH RESULT AND THE FACT THAT THE ISSUE IS ISOLATED TO ONE XPRESS INSTRUMENT. BASED ON THE SEVERITY AND PROBABILITY OF OCCURRENCE, THE OVERALL RISK IS DEEMED AS ACCEPTABLE PER GRIFOLS, SAN DIEGO RISK PROCEDURES. NO NEW RISKS WERE IDENTIFIED. NO FURTHER INFORMATION IS EXPECTED, THIS IS THE FINAL REPORT.