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
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo road; irvine, ca
• MDR Report Key: 9745217
• Report Number: 2016706-2020-00001
• Device Sequence Number: 11425700
• Product Code: JJY
• UDI-Device Identifier: 00847661004172
• UDI-Public: 00847661004172
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/24/2020
• 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