MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. LIQUID ASSAYED MULTIQUAL, LEVEL 3; MUITI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

Model Number 696

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 liquid assayed multiqual 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 for (b)(6) surface antigen ((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 march 04, 2020, a laboratory information manager from va medical center- (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 plashed 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.

• Brand Name: LIQUID ASSAYED MULTIQUAL, LEVEL 3
• 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: 9806098
• MDR Text Key: 228833364
• Report Number: 2016706-2020-00007
• Device Sequence Number: 1
• Product Code: JJY
• UDI-Device Identifier: 00847661001294
• UDI-Public: 00847661001294
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043208
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Model Number: 696
• Device Catalogue Number: 696
• Device Lot Number: 45793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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