MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC. ENVISION FLEX TARGET RETRIEVAL SOLUTION, LOW PH (50X) (LINK); IMMUNOHISTOCHEMISTRY, ANTIGEN RETRIEVAL REAGENT, IVD

Catalog Number K8005

Device Problems Labelling, Instructions for Use or Training Problem (1318); Improper or Incorrect Procedure or Method (2017)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/29/2017

Event Type  Injury  

Event Description

The customer reported an incident to dako on the (b)(6) 2017.Three female laboratory employees (initials (b)(6) and unknown) 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) and unknown) 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 °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.

Manufacturer Narrative

Final follow-up information: this mdr is connected to mdr2022180-2017-00002 and mdr2022180-2017-00004, as three employees exhibited symptoms at the same laboratory.Root cause investigation: this complaint is the first complaint received regarding allergic reaction for (b)(4) k8005 envision flex target retrieval solution, low ph (trs) kits sold since 2013.The trs device was retrieved from the customer.There was not sufficient volume to test the ph of the undiluted return.The diluted return tested within specification.The dako retainer tested within specification, both undiluted and diluted.None of the agilent laboratory personnel experienced any allergic reactions during testing.There were no remarks on the lot during production.Trs contains one substance classified as a sensitizer: 5-bromo-5nitro-1,3-dioxane (bronidox) (skin sens 1b).The content of bronidox does not trigger the classification as skin sensitizer.Due to that our safety data sheet, ifu, and label does not contain ghs label data related to the sensitizing properties.(us ghs classification as sensitizer us osha hazard communication 29cfr1910.1200 app a table a.4.5).Two agilent employees visited the site and inspected procedures related to the pt link and pt link instrument itself.No observations were made on procedures and the instrument works according to its specifications.The production site was scrutinized.No evidence was found of cross contamination of other substances that might cause an allergic or irritant reaction.The laboratory employee mg had a history of urticaria/hives, and mg treats herself when these reactions occurs with otc antihistamines (deslortadine teva 5 mg).No testing for allergens has taken place, hence the urticaria diagnosis is self-diagnosed.On two occasions, she experienced some small red dots on the neck during the time the pt link was present in the building.This resolved after leaving the building.Mg developed slight rashes as another colleague (initials unknown, mdr: 2022180-2017-00004) and the symptoms developed sometime during the time course of another laboratory employee la (mdr: 2022180-2017-00002).Mg does not know what caused these rashes and assumed that this might be due to the same suspected cause as la.Mg cannot remember the dates exactly but information has been provided that on the (b)(6) 2017.The reaction could not be a contact allergic dermatitis because of the time course and lack of contact.The reaction could have been a type i reaction due to the time course and clinical appearance, but it is less likely that the bronidox in the trs solution caused this reaction as the reactions reported to occur are irritant or allergic contact dermatitis and it is not known as a common cause of type i reactions.The correlation with mgs symptom and the pt link and trs as a cause seems unlikely, given the lack of direct contact with any solution or concentrated fumes of any substance used on the pt link.Conclusion: it is unclear whether this compound caused the symptoms mentioned for mg, and it cannot be concluded that the bronidox is the cause of this issue without specific allergic testing for this compound.Because this type of reaction has not been reported for trs and agilent has not seen this reaction previously in (b)(4) kits sold, it is considered remote that a reaction to the diluted fumes from the pt link would reoccur.Even if this did occur again, the reactions seen here resolved quickly with minor medical intervention, so the risk of serious harm is remote.This investigation is closed.

• Brand Name: ENVISION FLEX TARGET RETRIEVAL SOLUTION, LOW PH (50X) (LINK)
• Type of Device: IMMUNOHISTOCHEMISTRY, ANTIGEN RETRIEVAL REAGENT, IVD
• Manufacturer (Section D): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria CA 93013
• Manufacturer (Section G): DAKO NORTH AMERICA, INC.; 6392 via real; carpinteria CA 93013
• Manufacturer Contact: mani siravanta ; 6392 via real; carpinteria, CA 93013 ; 8055665462
• MDR Report Key: 6715863
• MDR Text Key: 80122022
• Report Number: 2022180-2017-00003
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: K8005
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 61