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 Consequences Or Impact To Patient (2199)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative crossmatch result of a proficiency sample with anti-human-globulin, anti-igg solidscreen ii when used on tango optimo.The customer reported that tango optimo called the result negative, but when she enlarged the image, the result appeared to be positive.The customer returned neither the supposedly defective product for investigational testing nor the proficiency sample that had caused a false negative test result.Testing in our quality control laboratory is still ongoing.The affected instrument tango optimo was inspected by one of our field-service-engineers.Evaluation of the data is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a false negative crossmatch result of a profiency sample with anti-human-globulin, anti-igg solidscreen ii when used on tango optimo.The customer reported that tango optimo called the result negative, but when she enlarged the image, the result appeared to be positive.The customer reported that the false negative reaction occurred when fy(a) positive proficiency red blood cells were tested with an proficiency sample containing an anti-fy(a).The customer returned neither the supposedly defective product for investigational testing nor the proficiency sample that had caused a false negative test result.Therefore our quality control laboratory tested their retained sample of anti-human-globulin, anti-igg solidscreen ii in crossmatch on tango optimo.For crossmatch testing red blood cells with different antigen constellations, e.G.Fy(a) positive and different samples, including anti-fy(a) were used.All positive and negative reactions were correct.We did not observe any false negative reaction.Our quality control laboratory had also participated in the same proficiency test that the customer complained and had passed.In quality control testing the proficiency sample for crossmatch yielded a clearly positive result on tango optimo.Testing by our quality control laboratory confirmed that the allegedly defective lot of anti-human-globulin, anti-igg solidscreen ii 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 instrument tango optimo was inspected by one of our field-service-engineers.No indication for an instrument malfunction could be identified; the instrument was confirmed to operate within specification.

• 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: 6310294
• Report Number: 9610824-2017-00006
• Device Sequence Number: 1007895
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 05/11/2017

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: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AHG ANTI-IGG, LOT 8608120-02, EXP. 08/19/2017; MLB2, LOT 8615110-00, EXP. 04/04/2018; SOLIDSCREEN II STRIP, LOT 8613040, EXP. 03/25/2018