MAUDE Adverse Event Report: BIO-RAD LABORATORIES LYPHOCHEK IMMUNOASSAY PLUS CONTROL; QUALITY CONTROL MATERIAL

Catalog Number 371

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

The labeling for lyphochek immunoassay plus control indicates that each human donor unit used to manufacture this control was "tested by fda accepted methods and found (b)(6).In addition, the labeling for lyphochek immunoassay plus control instructs the users to treat all human source material as potentially infectious and should be handled with the same precautions used with patient specimens.

Event Description

Customer was opening a glass vial of the quality control when a piece of broken glass cutting her right thumb.

• Brand Name: LYPHOCHEK IMMUNOASSAY PLUS CONTROL
• Type of Device: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): BIO-RAD LABORATORIES; 9500 jeronimo road; irvine CA 92618 2017
• Manufacturer (Section G): BIO-RAD LABORATORIES; 9500 jeronimo road; irvine 92618 2017
• Manufacturer Contact: elizabeth platt ; 9500 jeronimo road; irvine, CA 92618-2017 ; 9495981265
• MDR Report Key: 5417986
• MDR Text Key: 37724411
• Report Number: 2016706-2016-00001
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 02/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 371
• Device Lot Number: 40311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2014
• 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
• Patient Age: 30 YR
• Patient Weight: 68