LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 2
Received Oct 17, 2017 · Event occurred Sep 21, 2017
Report 2016706-2017-00002 · MDR key 6955643
Device
Generic name
Multi-analyte Controls Unassayed
Manufacturer
Bio-rad Laboratories, Inc.Catalog number
692
Lot number
31832
Product problems
- Human Factors Issue
- Human Factors Issue
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
BIO-RAD SHIPPING BOXES WERE LABELED AS REQUIRED BY THE UNITED STATES DEPARTMENT OF TRANSPORTATION (DOT) AND THE (B)(6)) FOR DRY ICE USING A "MISCELLANEOUS" HAZARD SYMBOL, CLASS 9.
Description of Event or Problem
A CUSTOMER REPORTED RECEIVING SEVERAL BOXES OF BIO-RAD CONTROLS, PACKED WITH DRY ICE. THE SHIPPING BOXES WERE PLACED INTO THE WALK-IN REFRIGERATOR. THE NEXT DAY TWO EMPLOYEES WALKED INTO THE REFRIGERATOR AND REPORTED TO THEIR SUPERVISOR THAT THEY EXPERIENCED A "FEELING OF SUFFOCATION AND/OR THROAT AND CHEST IRRITATION AND DRY MOUTH." BOTH EMPLOYEES WERE SENT TO THE EMERGENCY DEPARTMENT WHERE THEY WERE EXAMINED BY A TOXICOLOGIST MD. THEY RECEIVED AN EKG, PHYSICAL EXAMINATIONS, AND THEIR VITALS WERE MONITORED. THEY WERE SENT HOME. NO HOSPITALIZATION WAS REQUIRED AND NO FURTHER TREATMENT WAS RECEIVED.