Description of Event or Problem · 1
THE CUSTOMER CONTACTED THE BIOMERIEUX SUBSIDIARY IN (B)(6) REGARDING AN OPERATOR INJURY THAT OCCURRED DURING USE OF A BIOMERIEUX PRODUCT. WHILE STORING THE PRODUCT IN THE STORAGE WAREHOUSE, THE CUSTOMER DROPPED THE PRODUCT AND GOT SOME OF THE REAGENT ON THEIR HANDS. THE CUSTOMER WASHED THEIR HANDS AS INDICATED IN THE MATERIAL SAFETY DATE SHEET. AN HOUR AFTER THE INCIDENT OCCURRED, THE CUSTOMER BEGAN TO EXPERIENCE "TINGLING SENSATION" IN HER FINGERTIPS AND WRIST OF HER LEFT HAND, AND WENT TO THE HOSPITAL TO SEEK MEDICAL ASSESSMENT FROM A PHYSICIAN. THE "TINGLING SENSATIONS" SUBSIDED WHILE AT THE HOSPITAL AND THE CUSTOMER DID NOT REQUIRE ANY ADDITIONAL MEDICAL TREATMENT OTHER THAN BLOOD TESTING. THE CUSTOMER WAS MONITORED AT THE HOSPITAL FOR 14 HOURS, BUT MADE A FULL RECOVERY FROM THE INCIDENT. IT WAS NOTED THAT THE CUSTOMER WAS NOT WEARING ANY PROTECTIVE GEAR WHEN THE EVENT OCCURRED. AS INDICATED IN THE PACKAGE INSERT WARNINGS/PRECAUTIONS SECTION, "DO NOT ALLOW REAGENT TO COME INTO CONTACT WITH SKIN, EYES, OR CLOTHING." THE MATERIAL SAFETY DATA SHEET (MSDS) PROVIDES SPECIFIC INSTRUCTION ON HANDLING THIS REAGENT AND FIRST AID MEASURES IF AN ADVERSE EVENT OCCURRED. THE SAFETY DATA SHEET ALSO PROVIDES DETAILED INFO REGARDING PROTECTIVE GEAR TO WEAR WHEN HANDLING THIS PRODUCT. THE PRODUCT WAS NOT RETURNED FOR FURTHER INVESTIGATION. THERE IS NO INDICATION THAT THE REAGENT BOTTLE MALFUNCTIONED WHILE IT WAS BEING STORED IN THE WAREHOUSE. THIS COMPLAINT IS AN ISOLATED EVENT THAT IS NOT RELATED TO MALFUNCTION OF THE PRODUCT. THE CUSTOMER INDICATED THAT THEY WERE NOT WEARING PROTECTIVE GEAR AS INSTRUCTED IN THE MATERIAL SAFETY DATA SHEET WHEN HANDLING THIS REAGENT. THE ROOT CAUSE OF THE REPORTED EVENT IS USER ERROR. THE INSTRUCTIONS IN THE PACKAGE INSERT AND MSDA ARE ADEQUATE AND CORRECTLY INFORMS THE CUSTOMER OF SAFETY PRECAUTIONS TO REDUCE THE POTENTIAL OF AN ADVERSE EVENT. THIS EVENT IS BEING REPORTED DUE TO THE REQUIRED MEDICAL INTERVENTION (BLOOD TESTING AND ASSESSMENT BY A PHYSICIAN) TO PREVENT PERMANENT IMPAIRMENT/DAMAGE ASSOCIATED WITH THE USER ERROR.