MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LEVEL 3; MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

Catalog Number	27113
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The protocol provided by bio-rad for testing the liquichek immunoassay premium control indicated the product contains human source materials and should be considered potentially infectious and handled with the same precautions used with patient specimens in accordance with good laboratory practice.Each human donor unit used to manufacture this product was tested as required by fda accepted methods.Tests results were non-reactive or negative for evidence of infection due to human immunodeficiency virus (hiv), hepatitis b virus (hbv) and hepatitis c virus (hcv).This product may also contain other human source materials for which there are no approved tests.In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.
Event or Problem Description
On 08/21/2019, a nurse from (b)(6) hospital called bio-rad qsd technical support to report a potential adverse event.The nurse stated that one employees got their right eye splashed with level 3 of liquichek immunoassay premium control, lot # 27373.The eye was rinsed off.The employee was not wearing protective eye wear.The employee has the vaccination for (b)(6).The nurse practitioner will do a baseline testing and make decision about starting the employee on prophylactic treatment.The nurse indicated having a copy of the sds and bio-rad provided a copy of the package insert.

• Brand Name: LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LEVEL 3
• Common Device Name: MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine CA 92618 2017
• MDR Report Key: 9082451
• Report Number: 2016706-2019-00001
• Device Sequence Number: 2623362
• Product Code: JJY
• UDI-Device Identifier: 00847661005186
• UDI-Public: 00847661005186
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 27113
• Device Lot Number: 27373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other