BD MAX¿ ENTERIC BACTERIAL PANEL

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY A "FALSE POSITIVE" RESULT COMPLAINT WAS REPORTED AGAINST THE BD MAX INSTRUMENT, CATALOG NUMBER 441916, SERIAL NUMBER (B)(6). CUSTOMER REPORTED THAT THEY HAVE RECEIVED A "FALSE POSITIVE" ON EBP FOR CAMPY. INITIALLY THEY RECEIVED A POSITIVE RESULT WITH HIGH CT VALUES BUT THE CURVES WERE STRANGE. SAMPLE WAS REPEATED AND RESULTED IN A NEGATIVE RESULT. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE PERFORMED PM ON THE INSTRUMENT. PM INCLUDED CLEANING AND GREASING THE GUIDE RAILS, CALIBRATING THE AXES, AND NORMALIZATION OF BOTH READER. INSTRUMENT WAS RETURNED TO THE CUSTOMER FUNCTIONAL. NO PARTS WERE RETURNED TO BD FOR INVESTIGATION. COMPLAINT IS CONFIRMED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. INVESTIGATION CONSISTED OF A REVIEW OF THE INSTRUMENT INSTALLATION, SERVICE HISTORY, AND RELATED COMPLAINT DATA. BD WILL CONTINUALLY MONITOR FOR TREND.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CAMPY WAS DETECTED POSITIVE WITH A HIGH CT VALUE."

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD MAX¿ ENTERIC BACTERIAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CAMPY WAS DETECTED POSITIVE WITH A HIGH CT VALUE."