MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A; MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

Model Number 27104

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

The instruction for use provided by bio-rad for testing the liquichek cardiac markers plus control lt 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 for (b)(6) surface (b)(6), antibody to (b)(6), and antibody to (b)(6) 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) 2020, a medical technologist from (b)(6) lab called bio-rad qsd technical support to report a potential adverse event that occurred with an employee at their facility.The employee was opening a vial of liquichek cardiac markers plus control lt, level 1a, lot # 23694 and the contents splashed onto her right eye while not wearing safety goggles.The employee washed and flushed her eyes and also washed her face.The incident was reported to facilities health and the employee was seen by a doctor.No medical tests were done.The employee had all the screenings done at pre-employment time.The employee and facility have access to product's package insert, msds and coa.

• Brand Name: LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A
• Type of Device: MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine, ca
• Manufacturer (Section G): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine, ca
• Manufacturer Contact: maria zeballos ; 9500 jeronimo road; irvine, ca ; 9981200136
• MDR Report Key: 9745217
• MDR Text Key: 221576364
• Report Number: 2016706-2020-00001
• Device Sequence Number: 1
• Product Code: JJY
• UDI-Device Identifier: 00847661004172
• UDI-Public: 00847661004172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Model Number: 27104
• Device Catalogue Number: 27104
• Device Lot Number: 23694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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