MAUDE Adverse Event Report: LYPOCHEK DIABETES CONTROL

Catalog Number 740

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2014

Event Type  Injury  

Event Description

A laboratory employee was pippeting lyphochek diabetes control.While discarding a pipet tip containing the control, the tip bounced off the side of the biohazard waste container and hit the laboratory employee in the corner of her right eye.The laboratory employee removed her contact lens, irrigated her eye and sought medical attention.

Manufacturer Narrative

The labeling and certificate of analysis for lypochek diabetes control indicates that each human whole blood donor unit used to manufacture the product was tested by fda acceptable methods and found non-reactive for (b)(6) surface antigen (b)(6), antibody to (b)(6) and antibody to (b)(6).In addition, the manual instructs the users to treat all human source material as potentially infectious and should be handled with the same precautions use with patient specimens.

• Brand Name: LYPOCHEK DIABETES CONTROL
• Manufacturer Contact: elizabeth platt ; 9500 jeronimo rd.; irvine, CA 92618-2017 ; 9495981285
• MDR Report Key: 4276165
• MDR Text Key: 5295464
• Report Number: 2016706-2014-00003
• Device Sequence Number: 1
• Product Code: GGM
• Combination Product (y/n): N
• PMA/PMN Number: K070546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2014

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: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 740
• Device Lot Number: 33881
• Other Device ID Number: (01)00847661002185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2014
• Initial Date FDA Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other