ACL TOP 750 LAS

Additional Manufacturer Narrative

A COMPLAINT WAS REPORTED ON (B)(6)2024 REGARDING ACL TOP 750 LAS SN (B)(6), INDICATING THAT THE PROBE SCRAPED ACROSS FINGERTIPS OF THE TECHNOLOGIST WHEN SHE REACHED TOO FAR IN PAST CONVEYOR BELT TRYING TO ALIGN CUVETTES ON ACL TOP 750 LAS SN (B)(6). IT WAS NOTED THAT THE GLOVE THE TECHNICIAN WAS WEARING WAS STILL INTACT BUT A SMALL SCRATCH WAS SEEN ON HER FINGERTIP. THE INCIDENT IS RELATED TO USER ERROR -NOT USING PRECAUTION AS INSTRUCTED IN THE OPERATOR MANUAL. THE ACL TOP SERIES OPERATOR'S MANUAL CONFIRMED THAT THERE ARE APPROPRIATE INSTRUCTIONS AND CAUTIONS AS BELOW: "WARNING PIERCING HAZARD: DO NOT PUT HAND INSIDE INSTRUMENT WHILE IT IS IN MOTION." "BIOHAZARD:THE SAMPLE PROBE AND PIERCER PROBE SHOULD BE TREATED AS BIOHAZARDOUS ITEMS. LABORATORY PRECAUTIONS FOR BIOHAZARDOUS MATERIAL SHOULD BE TAKEN WHEN HANDLING AND DISPOSING OF THESE ITEMS". THERE WAS NO KNOWN ADVERSE EFFECT FROM THE SCRAPE. THE ACL TOP 750 LAS PERFORMED AS INTENDED WITH NO MALFUNCTION AND ITS LABELING PROVIDES APPROPRIATE WARNINGS TO THE USER REGARDING THE HAZARD. THEREFORE, NO REMEDIAL ACTION IS INDICATED AT THIS TIME.

Description of Event or Problem

A COMPLAINT WAS REPORTED ON (B)(6)2024 REGARDING ACL TOP 750 LAS SN (B)(6), INDICATING THAT THE PROBE SCRAPED ACROSS FINGERTIPS OF THE TECHNOLOGIST WHEN SHE REACHED TOO FAR IN PAST CONVEYOR BELT TRYING TO ALIGN CUVETTES ON ACL TOP 750 LAS SN (B)(6). IT WAS NOTED THAT THE GLOVE THE TECHNICIAN WAS WEARING WAS STILL INTACT BUT A SMALL SCRATCH WAS SEEN ON FINGERTIP. TECHNICIAN WENT TO EMERGENCY ROOM AND FOLLOWED UP WITH OCCUPATIONAL HEALTH. OCCUPATIONAL HEALTH PLACED HER ON A PEP FOR POTENTIAL EXPOSURE FOR 28 DAYS AND SCHEDULED FOLLOW-UP. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE SCRAPE.