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

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2018

Event Type  malfunction  

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 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
• Type of Device: MULTI-ANALYTE CONTROL,ALL KINDS (ASSAYED) PRODUCT CODE :JJY
• Manufacturer (Section D): BIO-RAD LABORATORIES INC; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer Contact: maria zeballos ; 9500; jeronimo road; irvine 92618-2017 ; 9495981220
• MDR Report Key: 7899083
• MDR Text Key: 121469073
• Report Number: 2016706-2018-00003
• Device Sequence Number: 1
• Product Code: JJY
• UDI-Device Identifier: 00847661001256
• UDI-Public: 00847661001256
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012513
• 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
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 642
• Device Lot Number: 57542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other