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U.S. Department of Health and Human Services

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

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BIO-RAD LABORATORIES, INC. LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1B MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) Back to Search Results
Model Number 27105
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
The instruction for use provided by bio-rad for testing 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 (b)(6) for (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 laboratory information manager from (b)(6) called bio-rad qsd technical support to report a potential adverse event that occurred with a technician at their facility. In the facility chemistry lab, the employee removed qc rack from instrument and emptied a rack of qc vials into sink. While dumping, the mixture of qc splashed into the technician's eyes. The technician was not wearing safety glasses, which is a laboratory requirement for ppe in this facility. The following qc products were on the qc rack and splashed in the technician's eyes: liquichek immunoassay plus control: trilevel: lot 41000. Liquichek cardiac markers plus control lt: level 2: lot 23692. Level 3: lot 23693. Level 1b: lot 23695. Liquid assayed multiqual: level 1: lot 45791. Level 3: lot 45793. The employee washed eyes immediately in the emergency eye wash station. The incident was reported to facilities health and the employee was sent to the employee health center for evaluation. No details of the visit to employee health center was provided. It was reported that no additional medical attention was required. The employee and facility was provided with package insert, sds and certificate of analysis for all 8 products that were splashed in the technician's eyes.
 
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Brand NameLIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1B
Type of DeviceMUITI-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 Key9806104
MDR Text Key263444062
Report Number2016706-2020-00005
Device Sequence Number1
Product Code JJY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050537
Number of Events Reported1
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 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date11/30/2020
Device Model Number27105
Device Catalogue Number27105
Device Lot Number23695
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/09/2020 Patient Sequence Number: 1
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