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

Catalog Number	751
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Codes	Rash (2033); Alteration In Body Temperature (2682)
Date of Event	09/10/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): BIO-RAD LABORATORIES INC; 9500 jeronimo road; irvine CA 92618 2017
• MDR Report Key: 6974280
• Report Number: 2016706-2017-00003
• Device Sequence Number: 977872
• Product Code: JJY
• UDI-Device Identifier: 00847661001584
• UDI-Public: 00847661001584
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K990888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: No Information
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 751
• Device Lot Number: 55661
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/24/2017
• 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