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

Catalog Number 850000010

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported 3 discrepant results when testing on tango infinity.Screening cells (biotestcell 3) were negative and the panel cells (biotestcell-i8) showed positive results and vice versa.The customer did neither return the supposedly defective products nor the samples that had caused discrepant test results.Therefore our quality control laboratory tested their retain samples of biotestcell-i8, #(b)(4) and biotestcell 3, #(b)(4) with different samples and controls.The antibodies: anti-e, anti-jka and an anti-d were also tested on tango infinity.All positive and negative reactions were correct for antibody screen and identification.We did not observe any false negative reactions.Testing by the quality control laboratory confirmed that the allegedly defective lots of biotestcell-i8 and biotestcell 3 function 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 our field service engineers.A buildup on outside of the spolv was observed and therefore the wash station pump and check valve with associated tubing were replaced.After performing post service verification procedure the instrument was confirmed functioning within specification.

• 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: 6803050
• MDR Text Key: 83305498
• Report Number: 9610824-2017-00058
• 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: 08/18/2017

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: 07/21/2017
• Initial Date FDA Received: 08/18/2017
• 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