MAUDE Adverse Event Report: BIO-RAD LABORATORIES INC LIQUICHEK LIPIDS CONTROL ,LEVEL 2; MULTI-ANALYTE CONTROL,ALL KINDS (ASSAYED) PRODUCT CODE :JJY

Catalog Number	642
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The labeling for liquichek lipids,control indicates this product manufactured from human source material components and contains a warning statement and a caution symbol indicating the product contains human source material and must be treated as potentially infectious.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 (b)(6) a physician assistant called to report that she had a patient seeking treatment.The patient splashed liquichek lipids control, lot 57542, into her right eye and on her left cheek.The user was not wearing laboratory goggles but was wearing regular eyeglasses.Physician assistant irrigated her eye with saline.

• Brand Name: LIQUICHEK LIPIDS CONTROL ,LEVEL 2
• Common Device Name: MULTI-ANALYTE CONTROL,ALL KINDS (ASSAYED) PRODUCT CODE :JJY
• Manufacturer (Section D): BIO-RAD LABORATORIES INC; 9500 jeronimo road; irvine CA 92618 2017
• MDR Report Key: 7899083
• Report Number: 2016706-2018-00003
• Device Sequence Number: 165153
• Product Code: JJY
• UDI-Device Identifier: 00847661001256
• UDI-Public: 00847661001256
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K012513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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: 04/30/2019
• Device Catalogue Number: 642
• Device Lot Number: 57542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/21/2018
• 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