MAUDE Adverse Event Report: BIO-RAD LABORATORIES LIQUICHEK UNASSAYED CHEMISTRY CONTROL- LEVEL 2; MULTI-ANALYTE CONTROL,UNASSAYED ,PRODUCT CODE OHQ

Lot Number	31872
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6), a health coordinator from the (b)(6), called bio-rad to inquire about liquichek unassayed chemistry containing any infectious disease material in the product.She stated that a technician splashed a small amount of the level 2 control into her eye while pipetting the control from the primary vial into another vial which was going to be placed on an instrument.They had the technician flushed out the eye with water for several minutes.They also conducted the following medical tests: (b)(6).No other detailed information was provided.
Event or Problem Description
On (b)(6), a health coordinator from the (b)(6), called bio-rad to inquire about liquichek unassayed chemistry containing any infectious disease material in the product.She stated that a technician splashed a small amount of the level 2 control into her eye while pipetting the control from the primary vial into another vial which was going to be placed on an instrument.They had the technician flushed out the eye with water for several minutes.They also conducted the following medical tests: (b)(6).No other detailed information was provided.

• Brand Name: LIQUICHEK UNASSAYED CHEMISTRY CONTROL- LEVEL 2
• Common Device Name: MULTI-ANALYTE CONTROL,UNASSAYED ,PRODUCT CODE OHQ
• Manufacturer (Section D): BIO-RAD LABORATORIES; 9500; jeronimo road; irvine CA 92618 2017
• MDR Report Key: 8044607
• Report Number: 2016706-2018-00005
• Device Sequence Number: 13904949
• Product Code: OHQ
• UDI-Device Identifier: 00847661000013
• UDI-Public: 00847661000013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

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: 01/31/2020
• Device Lot Number: 31872
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/06/2018
• 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