BBL CRYSTAL ENTERIC/NONFERMENTER ID KIT

Description of Event or Problem

A STAFF MEMBER WHO HAD HANDLED THE KIT INOCULATED A PANEL WITH A PATIENT SAMPLE AND CONTRACTED (B)(6) WHICH RESULTED IN HOSPITALIZATION. SHE WAS A SENIOR MEMBER OF STAFF WHO WAS AWARE OF THE RISKS AND HAND WASHING ETIQUETTE ETC. THE LAB STATES THAT WHEN THEY GOT THE CRYSTAL STRIP OUT OF THE HOT ROOM TO READ, THAT THE PLASTIC WAS WET AND AT THE TIME THOUGHT IT WAS CONDENSATION. THE STAFF MEMBER HAS FULLY RECOVERED. THE HSE HAVE BEEN INTO THE LABORATORY FOLLOWING THE RIDDOR REPORT AND ARE SATISFIED WITH LABORATORY SAFETY PRECAUTIONS. THE HOSPITAL STATED THAT THE EXACT CAUSE OF THE CONTAMINATION COULD NOT BE DETERMINED FROM THEIR RCA BUT WAS LIKELY TO BE THE CRYSTAL PANEL BEING CONTAMINATED.

Additional Manufacturer Narrative

NO RETURNS WERE RECEIVED FOR INVESTIGATION. CRYSTAL KIT BASES AND LIDS FROM RETENTION SAMPLE WERE TESTED FOR LEAKAGE. NO LEAKAGE WAS PRESENT. THE COMPLAINT COULD NOT BE CONFIRMED. THERE ARE NO TRENDS FOR THIS TYPE OF ISSUE. NO ACTION WILL BE AT THIS TIME AND QUALITY WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS TYPE OF COMPLAINT.