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

Catalog Number 27113

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

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 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
• Type of Device: MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer (Section G): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer Contact: maria zeballos ; 9500 jeronimo road; irvine, CA 92618-2017 ; 9499981200
• MDR Report Key: 9082451
• MDR Text Key: 188934565
• Report Number: 2016706-2019-00001
• Device Sequence Number: 1
• Product Code: JJY
• UDI-Device Identifier: 00847661005186
• UDI-Public: 00847661005186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 27113
• Device Lot Number: 27373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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