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

Catalog Number 171

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

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 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
• Type of Device: HEMOGLOBIN CONTROL
• Manufacturer (Section D): BIO-RAD LABORATORIES INC; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer Contact: maria zeballos ; 9500; jeronimo road; irvine 92618-2017 ; 9495981220
• MDR Report Key: 7906291
• MDR Text Key: 121864315
• Report Number: 2016706-2018-00004
• Device Sequence Number: 1
• Product Code: GGM
• UDI-Device Identifier: 00847661000839
• UDI-Public: 00847661000839
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 171
• Device Lot Number: 38561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other