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	12/27/2017
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 reported false positive reactions with erytype s abd+rev.A1, b when used on tango optimo.The customer stated that reactions were not resuspended on tango optimo and therefore interpreted as being positive.The customer returned neither the supposedly defective product nor the specimens that had caused false positive reactions.Therefore our quality control laboratory tested their retention sample of erytype s abd+rev.A1, b with different red blood cells on tango optimo.All positive and negative reactions were correct.All negative reactions were completely resuspended.We did not observe any false positive reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of erytype s abd+rev.A1, b functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango optimo was inspected by our field service engineers and the orbital shaker's was found to be in need of repair.The right needle adapter's cable was damaged, bubbles were found inside the right syringe and scratches on the right needle.The right syringe, right needle adapter and right needle were replaced.After this intervention, a qc was run and all results were as expected.The system performance was validated and found to be within manufactures specification.The instrument related complaint will be closed as confirmed, because change of defective and affected parts by bubbles and scratches (single event) resolved the issue.The tango optimo was confirmed to operate in specification by our field service engineers upon service intervention.

• 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: 7208856
• Report Number: 9610824-2017-00098
• Device Sequence Number: 834321
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/22/2018

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1