MAUDE Adverse Event Report: BIO-RAD LABORATORIES INC LIQUICHEK DIABETES CONTROL LEVEL 1; HEMOGLOBIN CONTROL

Catalog Number	171
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The labeling for liquichek diabetes control indicates this product is manufactured from human source material components.The labeling has a warning statement and a caution symbol indicating the product contains human source material and must be treated as potentially infectious.Each human donor unit used to manufacture this product was tested as required by fda accepted methods.Tests results were non-reactive or negative for evidence of infection due to human immunodeficiency virus (hiv), hepatitis b virus (hbv) and hepatitis c virus (hcv).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 or Problem Description
On september 06, 2018, bio-rad qsd, (b)(4) received a report for a potential adverse event where a laboratory technician splashed liquichek diabetes control lot # 38560 into her eye.

• Brand Name: LIQUICHEK DIABETES CONTROL LEVEL 1
• Common Device Name: HEMOGLOBIN CONTROL
• Manufacturer (Section D): BIO-RAD LABORATORIES INC; 9500 jeronimo road; irvine CA 92618 2017
• MDR Report Key: 7906291
• Report Number: 2016706-2018-00004
• Device Sequence Number: 1797254
• Product Code: GGM
• UDI-Device Identifier: 00847661000839
• UDI-Public: 00847661000839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052838
• 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): 09/24/2018

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: 02/29/2020
• Device Catalogue Number: 171
• Device Lot Number: 38561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/25/2018
• 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