IMMUNOASSAY PLUS CONTROL, 5 ML

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for IMMUNOASSAY PLUS CONTROL, 5 ML manufactured by Bio-rad.

Event Text Entries

[42162976] I am a medical technologist. I work at (b)(6). I want to report a product quality problems of bio-rad company. On (b)(6) 2016 at 10:40 am, when i opened the cp of a new "immunoassay plus control" which is a product by bio-rad of american company, my right thumb was injured by the glass fragment around the neck of vial. The glass fragment was so big that it caused uncontrolled bleeding. The wound was very painful. I used the "immunoassay plus control" for thyroid gland disease. At the same time i am in charge of (b)(6) test. I deal with pt specimens of an infection disease. On (b)(6) 2016 before 10:40 am, several pts carried virus on (b)(6) were confirmed. It is so dangerous that when i deal with pts' who carried (b)(6) virus i was injured. It is possible that i am infected by infection virus. Dates of use: 3 years. Reason for use: is a part of work. Product is not compounded. Product is not over-the-counter. Event abated after use: stopped or dose reduced? No. Event reappeared after reintroduction? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5061487
• MDR Report Key: 5551775
• Date Received: 2016-04-01
• Date of Report: 2016-04-01
• Date of Event: 2016-01-07
• Date Added to Maude: 2016-04-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: IMMUNOASSAY PLUS CONTROL, 5 ML
• Generic Name: IMMUNOASSAY PLUS CONTROL, 5 ML
• Product Code: JJY
• Date Received: 2016-04-01
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIO-RAD

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-04-01