THE BD MAX SYSTEM IS INTENDED FOR IN VITRO DIAGNOSTIC (IVD) USE IN PERFORMING FDA CLEARED OR APPROVED NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. THE BD MAX SYSTEM IS CAPABLE OF AUTOMATED EXTRACTION AND PURIFICATION OF NUCLEIC ACIDS FROM MULTIPLE SPECIMEN TYPES, AS WELL AS THE AUTOMATED AMPLIFICATION AND DETECTION OF TARGET NUCLEIC ACID SEQUENCES BY FLUORESCENCE-BASED PCR. THE COMPLAINT OF ?THE INSTRUMENT IS ALLOWING THEM TO RUN WHILE THE DOOR IS OPEN? WAS INVESTIGATED BY THE FIELD SERVICE ENGINEER. THE FIELD SERVICE ENGINEER DISPATCHED TO THE SITE FOUND THAT THE DOOR WAS LOCKED AND WOULD NOT OPEN DURING THE RUNS. THE FSE ADJUSTED THE DOOR MAGNET AS A PRECAUTIONARY MEASURE, WHICH ALLOWS THE CUSTOMER TO OPERATE THE INSTRUMENT UNDER NORMAL CONDITIONS WITHOUT FURTHER INCIDENT. THE QUALITY INVESTIGATION IS STILL UNDERWAY, AND A SUPPLEMENTAL REPORT WILL BE FILED AT THE CONCLUSION OF THIS INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.
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Patient 1
CUSTOMER REPORTED THAT THE BD MAX WOULD RUN WHILE THE DOOR WAS OPEN. NO INJURIES REPORTED.
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Patient 1
BD QUALITY HAS COMPLETED THE INVESTIGATION FOR THE BD MAX? SYSTEM RUNNING WHILE THE DOOR IS OPEN AND WAS UNABLE TO CONFIRM THE CUSTOMER COMPLAINT. THE DOOR ON THE BD MAX? SYSTEM AUTOMATICALLY LOCKS DURING SAMPLE PREPARATION TO PREVENT THE USER FROM ACCESSING THE INSIDE OF THE INSTRUMENT. THE INSTRUMENT DOES ALLOW THE USER TO OPEN THE DOOR DURING PCR WHEN THE ROBOT IS NOT IN MOTION TO SET UP ADDITIONAL RUNS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO TROUBLESHOOT THIS CUSTOMER COMPLAINT. THE FSE WAS UNABLE TO REPRODUCE THE COMPLAINT. NO MATERIALS WERE RETURNED AS A RESULT OF THE COMPLAINT AS NO REPLACEMENT MATERIALS WERE REQUIRED. NO TRENDS OR NEW HAZARDS HAVE BEEN IDENTIFIED FOR THIS FAILURE; THEREFORE, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. QUALITY WILL CONTINUE TO MONITOR.