MAUDE Adverse Event Report: BIO-RAD LABORATORIES INC LIQUICHEK SPINAL FLUID CONTROL LEVEL 1; MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

Catalog Number 751

Device Problem Human Factors Issue (2948)

Patient Problems Rash (2033); Alteration In Body Temperature (2682)

Event Date 09/10/2017

Event Type  malfunction  

Manufacturer Narrative

Bio-rad sent samples of liquichek spinal fluid lot 55660 to two different labs using two different test methods (hologic procleix grifols nat and roche mpx v2.0 multiplex nat) to analyze for (b)(6).Results were reported as (b)(6).Bio-rad also reviewed the vendor certificate of analysis (coa) for all human sourced raw materials used.The raw materials indicted (b)(6) results for (b)(6) using fda approved methods.

Event Description

On october 10, 2017 bio-rad (b)(4) received a report from the university (b)(6) in the (b)(6) of an eye splash involving liquichek spinal fluid control that had occurred approximately 4 weeks earlier.A lab technician had splashed the spinal fluid control into her eye.She had recently developed a "rash and temperature rise consistent with (b)(6)".

• Brand Name: LIQUICHEK SPINAL FLUID CONTROL LEVEL 1
• Type of Device: MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): BIO-RAD LABORATORIES INC; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer Contact: suzanne parsons ; 9500 jeronimo road; irvine, CA 92618-2017 ; 9495981200
• MDR Report Key: 6974280
• MDR Text Key: 90953373
• Report Number: 2016706-2017-00003
• Device Sequence Number: 1
• Product Code: JJY
• UDI-Device Identifier: 00847661001584
• UDI-Public: 00847661001584
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K990888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 751
• Device Lot Number: 55661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other