APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR

Additional Manufacturer Narrative

ON (B)(4) 2016 A (B)(4) SCIENTIFIC FIELD SERVICE ENGINEER VISITED THE (B)(6) TO RESPOND TO THE USER REPORT AND SERVICE THE 7500 FAST DX INSTRUMENT AFTER THE INCIDENT. THE ENGINEER NOTED THE LAPTOP COMPUTER WAS ON LOCATED ON A HOLDER ON TOP OF THE 7500 FAST DX INSTRUMENT. THE HOLDER WAS MADE OF METAL WITH RUBBER FEET AND RUBBER PADS. THE LAPTOP MOUSE WAS PLACED ON A MOUSEPAD BESIDE THE 7500 FAST DX INSTRUMENT. THE INSTRUMENT AND MOUSEPAD WERE LOCATED ON A LAB BENCH MADE OF METAL WITH A PLASTIC RESIN TOP. THE ENGINEER VISUALLY INSPECTED THE 7500 FAST DX AND NOTICED FOUR (4) LOOSE SCREWS IN BACK OF THE INSTRUMENT. IT APPEARED THAT THE LOOSE SCREWS CAUSED THE INSTRUMENT COVER TO BECOME LOOSE. THE COVER WAS REMOVED FROM THE INSTRUMENT AND GROUNDING CABLES INSIDE THE INSTRUMENT WERE VISUALLY INSPECTED FOR ATTACHMENT TO CORRECT SOURCES. ALL GROUNDING CABLES INSIDE THE INSTRUMENT WERE ATTACHED CORRECTLY. THE ENGINEER THEN TIGHTLY SCREWED IN THE COVER TO CLOSE THE INSTRUMENT. THE LAPTOP AND INSTRUMENT WERE BOTH PLUGGED INTO A CYBER POWER UPS / SURGE PROTECTOR. THE ENGINEER CHECKED THE ELECTRICAL OUTLET FOR PROPER GROUNDING USING A LINE MONITORING KIT. THE OUTLET DID NOT HAVE ANY DEFECTS. THE POWER CORD FOR THE LAPTOP WAS REPLACED AND THE INSTRUMENT AND LAPTOP WERE TURNED ON. BOTH THE INSTRUMENT AND LAPTOP WERE OPERATING CORRECTLY. SELF-TESTS ON THE 7500 FAST DX SYSTEM WERE RUN. THE INSTRUMENT PASSED SPECIFICATIONS. NO VISUAL SIGNS OF ELECTRICAL DAMAGE ON THE INSTRUMENT OR LAPTOP WERE OBSERVED. NO SIGNS OF SOFTWARE CORRUPTION FROM ELECTRICAL DAMAGE WERE OBSERVED. ON (B)(4) 2016 A REPRESENTATIVE FROM (B)(4) CONTACTED THE REPORTER, (B)(6), TO INQUIRE ABOUT ADVERSE HEALTH EFFECTS FROM THE INCIDENT. THE USER REPORTED NO ADVERSE HEALTH ISSUES AND STATED THE FACILITY IS WAITING TO INSTALL A STATIC MAT, OR OTHER SAFETY MEASURE, BEFORE USING THE INSTRUMENT AGAIN.

Description of Event or Problem

A USER REPORTED A "SHOCK" WHILE WEARING GLOVES THAT FELT LIKE A SURGE AND VIBRATION. THE USER HAD ONE HAND ON THE COMPUTER MOUSE AND ONE HAND ON THE COMPUTER KEYBOARD WITH THE 7500 FAST DX INSTRUMENT TURNED ON. THE SENSATION LASTED A FEW SECONDS AND CAUSED THE USER TO FEEL TIRED AND A SLIGHT TINGLING SENSATION IN THEIR FOREHEAD. THE USER REPORTED RECOVERING FROM THE INITIAL SHOCK QUICKLY. THEY WERE SENT TO THE EMERGENCY ROOM FOR PRECAUTION AND WERE RELEASED BY THE EMERGENCY ROOM DOCTOR WITH NO FURTHER HOSPITALIZATION. NO ADVERSE REACTIONS WERE REPORTED.