MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 2; MULTI-ANALYTE CONTROLS UNASSAYED

Catalog Number	692
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bio-rad shipping boxes were labeled as required by the united states department of transportation (dot) and the (b)(6)) for dry ice using a "miscellaneous" hazard symbol, class 9.
Event or Problem Description
A customer reported receiving several boxes of bio-rad controls, packed with dry ice.The shipping boxes were placed into the walk-in refrigerator.The next day two employees walked into the refrigerator and reported to their supervisor that they experienced a "feeling of suffocation and/or throat and chest irritation and dry mouth." both employees were sent to the emergency department where they were examined by a toxicologist md.They received an ekg, physical examinations, and their vitals were monitored.They were sent home.No hospitalization was required and no further treatment was received.

• Brand Name: LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 2
• Common Device Name: MULTI-ANALYTE CONTROLS UNASSAYED
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.; 9500 jeronimo rd.; irvine CA 92618 2017
• MDR Report Key: 6955643
• Report Number: 2016706-2017-00002
• Device Sequence Number: 13651813
• Product Code: OHQ
• UDI-Device Identifier: 00847661000013
• UDI-Public: 00847661000013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2017

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: 692
• Device Lot Number: 31832
• 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: 09/22/2017
• Initial Report FDA Received Date: 10/17/2017
• 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