Description of Event or Problem · 0
ON MAY 7, 2020, CUSTOMER CALLED TECHNICAL SUPPORT (TS) AND REPORTED HEARING A LOUD NOISE DURING A TEST RUN ON A REVOGENE INSTRUMENT AND THEN SMELLED A BURNING ODOR. CUSTOMER STATED THAT SHE IMMEDIATELY TURNED OFF THE REVOGENE INSTRUMENT. TS INSTRUCTED CUSTOMER TO TURN THE REVOGENE INSTRUMENT BACK ON IN ORDER TO OPEN THE LID TO SEE IF A PIE WAS DISLODGED, AS THIS COULD POTENTIALLY CAUSE THE SERIES OF EVENTS THAT WERE BEING REPORTED. CUSTOMER STATED THAT SHE WAS PERFORMING ONE PATIENT TEST AND THE REST WERE MOCK PIES. TS ASKED CUSTOMER IF MOCK PIES ARE REMOVED AFTER EACH TEST RUN AND CUSTOMER STATED THAT, YES, THEY WERE. ONCE THE LID WAS OPENED, CUSTOMER STATED THAT THE PIE CONTAINING THE PATIENT SAMPLE APPEARED TO BE SLIGHTLY RAISED. TS ADVISED CUSTOMER TO CHECK THAT ALL PIES ARE SECURE, EVEN AFTER PUTTING RETENTION RING IN PLACE. TS ALSO ADVISED CUSTOMER TO ENSURE THAT THE SENSORS ON THE LID DO NOT APPEAR TO HAVE MATERIAL COATING THEM AS A RESULT OF THE DISLODGED PIE, AND IF SO, TO WIPE THEM OFF WITH ALCOHOL. TS ADVISED CUSTOMER THAT SHE WILL NEED TO REPEAT THE PATIENT TEST FROM THE BEGINNING AS THE PIE CAN NOT BE REUSED. CUSTOMER TO REPEAT TESTING. CUSTOMER REPORTED THAT REPEAT TESTING WORKED AS EXPECTED AND THERE HAVE BEEN NO FURTHER ISSUES. CUSTOMER IS SATISFIED WITH TS ASSISTANCE AND FOLLOW-UP. IT IS A KNOWN FAILURE MODE THAT IMPROPERLY SETTING PIES IN THE ROTOR CAN LEAD TO A "BLOCKED ROTOR" AND LEFT UNATTENDED CAN RESULT IN THE SMELL OF HEATED PLASTIC; HOWEVER, THE INSTRUMENT WILL SHUT DOWN IF THE ROTOR BECOMES BLOCKED. THE PRODUCT LABELING DESCRIBES THE IMPORTANCE OF SEATING PIES IN THE ROTOR PROPERLY. THIS COMPLAINT WAS FOUND AS PART OF A REVIEW FOR MDR 1524213-2024-00001 AND AFTER CAREFUL REVIEW, MERIDIAN HAS ELECTED TO REPORT OUT OF AN EXTREME ABUNDANCE OF CAUTION. THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM AS A RESULT OF THE BURNING SMELL.