MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC BIOPLEX 2200; BIOPLEX 2200 SYSTEM

Model Number	BIOPLEX 2200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Laboratory manager called on (b)(6), 2017 to inform that a technician was injured (cut) while removing a stuck sample tray.They are concerned because they were running (b)(6) samples during the incident.Bio-rad technical support representative contacted the injured technician and gathered some information regarding the incident.The technician informed that the incident happened on (b)(6) 2017.He was running (b)(6) samples when he received an error.He can't remember what the error was but he noticed the sample tray was stuck.He removed the front cover of the bioplex and tried to get the rack out with some force and that is when he cut his hand.He was wearing lab coat, gloves and eye shield.He immediately rinsed his hand with soap water, wiped with alcohol swab and applied bandage.He went to seek treatment the next day on (b)(6) 2017.He was tested for (b)(6) and the result was negative.He was also given prophylaxis treatment of isentress 400mg twice daily and truvada 200mg daily for 30 days.He was retested for (b)(6) in october and the result was negative.Customer was advised not to remove stuck trays with force.He was directed to the user manual and was given instruction to safely remove the tray using the maintenance user interface.
Event or Problem Description
Received a call on (b)(6) 2017.Technician reported that while he was running a sample on september (b)(6) 2017, he received an error message.The sample rack was stuck.He removed the front cover to try to get the rack out with some force and that is when he cut his hand.He was running hiv test on the system.

• Brand Name: BIOPLEX 2200
• Common Device Name: BIOPLEX 2200 SYSTEM
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC; 4000 alfred nobel dr.; hercules CA 94547
• MDR Report Key: 7113356
• Report Number: 1000135116-2017-00001
• Device Sequence Number: 19203183
• Product Code: NSU
• UDI-Device Identifier: 00847865002813
• UDI-Public: 00847865002813
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: BK140112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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: Medical Technologist
• Device Model Number: BIOPLEX 2200
• Device Catalogue Number: 660-0000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/13/2017
• 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
• Patient Age: 29 YR
• Patient Weight: 68