MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. VIROTROL I; KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS

Catalog Number	00100E
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The labeling for virotrol indicates this product contains biological source material and should be treated as potentially infectious.Each human serum or plasma donor unit used in the preparation of this product was tested for the presence of hbsag, antibodies to hiv-1 and hiv-2 and antibodies to hcv using licensed reagents.Human source materials reactive for viral hepatitis markers and antibodies to retroviruses used to produce this product have been treated to inactivate infectious agents.However, no known test method can assure that products derived from human sources will not transmit infection.It is recommended that this product and all human specimens be handled in accordance with biosafety level 2 practices as described in (b)(4) and (b)(4), biosafety in microbiological and biomedical laboratories, or other equivalent guidelines.
Event or Problem Description
On (b)(6) 2018 bio-rad qsd technical support received a report from (b)(6) reporting that a laboratory individual had splashed virotrol i control into her eye.The individual cleaned her eyes by splashing water.She also saw a doctor in the hospital and was tested for (b)(6) antibody.The incident occurred in the hospital lab.

• Brand Name: VIROTROL I
• Common Device Name: KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo rd.; irvine CA 92618 2017
• MDR Report Key: 7246263
• Report Number: 2016706-2018-00001
• Device Sequence Number: 1249819
• Product Code: KSF
• UDI-Device Identifier: 00847661004240
• UDI-Public: 00847661004240
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: BK930016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 00100E
• Device Lot Number: 119100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other