[80119421]
The customer reported an incident to dako on the (b)(6) 2017. Three female laboratory employees ((b)(6)) were reported to have allergic reactions to the product envision flex target retrieval solution, low ph (50x) (link), code no k8005. The product k8005 is a vial in the sk00621-2 kit, lot 10121768, exp. Date 2017-10-31. It was reported that the reactions varied in intensity and consisted of erythema, burning/stinging/itching feeling, red spots and/or blisters on cheeks and neck. (b)(6) exhibited symptoms on (b)(6) 2017; (b)(6) was the only person to exhibit the more major symptoms. According to the information received by dako, (b)(6) experienced symptoms on (b)(6) 2017 and no other times could be recalled. Deparaffinization, rehydration and target retrieval of the tissue slides was performed in the pt link instrument using k8005 on the dates of (b)(6) 2017. None of the three persons ((b)(6)) who had the reactions were trained to use product k8005 or the pt link instrument. (b)(6) worked partly in the same room as the pt link was situated the (b)(6) 2017. Apart from this the three affected persons were not in the room on the dates set forth above. Other personnel at the site were trained on the use of the product and instrument by an application specialist on the dates of (b)(6) 2017. The five trained employees have not reported any reactions. On (b)(6) 2017, (b)(6) worked in another laboratory down the corridor. The customer prepared the k8005 solution in the pt link as trained and the run was started. When half of the heating incubation time at 97 degrees c had passed, (b)(6) came to the lab (the door to the corridor closed) and told the customer that she felt the allergic reaction again and would go home. On (b)(6) 2017 a closed vial of k8005 in a sealed bag was placed next to (b)(6) computer. On (b)(6) 2017, (b)(6) was working on the same floor where the pt link instrument had been moved within the laboratory; (b)(6) was working in the room next to the laboratory where the k8005 was being used, both experienced symptoms. The symptoms resolved when (b)(6) left the building. (b)(6) was treated with cortisone (betapred - betametasonnatriumfosfat 0,5 mg tablets), administered start and end date (b)(6) 2017. (b)(6) treated herself with an antihistamine, deslortadine teva tablets (5mg), on (b)(6) 2017, as she experiences hives now and then. Root cause is being investigated.
Patient Sequence No: 1, Text Type: D, B5