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	Injury (2348)
Date of Event	08/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer injured her hand while replacing a part on tango optimo.The customer took off the part above the plate loading area to take off the cover surrounding the plate stacker.During that time, the tango optimo was switched off.This was not advised to her from our technical service.The customer had already done this on her own and notified the blood bank specialist of her injury.The customer had a software error and it appeared that no plates were on board.The customer did not call tech support and thought the only way to unload plates was to go in and manually take the plates out.She was not a customer trained on the tango optimo.The customer took the covers off the entire plate stacker area and had trouble placing a part back on.We received information that the pinch the customer suffered was harmless, the customer is fine and there is no mark, cut or scrape.This incident happened because of unintended use by the customer.The customer was not qualified to do the troubleshooting and did not call tech support.Regarding the harmless injury, the customer stated she was fine.We consider offering a refresher course for the customer in order to avoid this kind of injury 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: 5920415
• Report Number: 9610824-2016-00055
• Device Sequence Number: 16363529
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/01/2016

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): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2016
• Initial Report FDA Received Date: 09/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1