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

Catalog Number 850000010

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

This is our combined initial and final report on this incident.

Event Description

The customer discarded all reagents and so the supposedly defective product was not available for investigational testing.Therefore our quality control laboratory tested the retained samples solidscreen ii controls (sc ii control lot # 80651410-00, scii control b lot # 8637070-00) on tango infinity with the same reagents that were used by the customer.The reagents were tested with biotestcell 3.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by the quality control laboratory confirmed that the allegedly defective lots of solidscreen ii controls functions correctly.A review of the batch record documentation showed no irregularities which might have negative influences on the quality of the allegedly defective lots.The affected tango infinity was inspected by one of our field service engineers.A partial metrology was performed including performance verification.The check valve for the wash station was noticed to fail and it was replaced.The instrument was confirmed to return operating within specification by the fse.The customer will be informed that the instrument does flag failed qc results and meanwhile, a new flush pump with integrated check valve is available (service bulletin t-223i, distributed on july 18, 2017), which prevents issues with the previous check valve part.

• Brand Name: TANGO INFINITY
• Type of Device: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6739957
• MDR Text Key: 81269584
• Report Number: 9610824-2017-00048
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: 07611969961719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/25/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 850000010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1