MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH TANGO OPTIMO; AUTOMATED BLOOD BANK ANALYSER SYSTEM

Catalog Number	848 900 010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
During the process of performing the monthly maintenance the customer had removed the disposable cup and the splash bowl.The customer had rinsed both with di water, but did not notice remaining liquid on the splash bowl.When replacing the splash bowl, the customer thinks a few drops got in her eye, but the customer is not sure.The customer says the drop got in her eye from underneath her glasses.The customer took precaution and went to the employee health office.Still we are not in the position to provide a conclusive statement.From today's perspective we can say that it is possible that a handling issue from customer side might be causative and that the instrument is working within specifications.We are currently waiting for update information concerning customer's condition and the instruments performance.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
A clear liquid splash from suspension cup went into customer's eye when the customer was in the process of performing the monthly maintenance on their tango optimo.The customer had removed the disposable cup and the splash bowl.She had rinsed both with di water, but did not notice remaining liquid on the splash bowl.The customer was wearing glasses but the liquid went up under her glasses.This is a case of unintended use by the customer.We kindly suggest carefully inspecting the splash bowl for any remaining liquid and in either case wearing safety glasses.No information was provided about the customer's condition.But, due to the presence of clear liquid (probably water) inside the splash, it is assumed that the customer was not injured.We will offer a refresher course for the customer in order to avoid this kind of splash in the future.

• Brand Name: TANGO OPTIMO
• Common Device Name: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6427120
• Report Number: 9610824-2017-00021
• Device Sequence Number: 317213
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: BK080013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 848 900 010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1