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

Model Number	850000010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false negative respectively weaker antibody screening results with biotestcell 3 on tango infinity.The customer stated that they were running a correlation study with tango infinity, an instrument of a competitor (echo) and in the manual tube method with an enhancement medium.He stated that in four cases, the reactions on tango infinity were false negative respectively weaker positive than expected.The specificity of the affected antibodies was anti-fy(a), anti-k and twice an anti-jk(a).The customer returned neither the supposedly defective product for investigational testing nor the specimens that caused false negative test results.At the time the customer filed his complaint, the supposedly defective lot biotestcell 3 was already expired.Therefore the retention sample could not be tested in our quality control laboratory.Due to the fact that the supposedly defective product was expired and no patient samples are available, an investigation could not be carried out.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot regarding the affected tango infinity, our technical service requested more information on this incident, like e.G.Colored result images showing overview, image details and process data of the corresponding result in question via screen shots made by the tango optimo/infinity pc prior to validation as well as a copy of the log files and a field service report.No further information has been provided so far.We are not in the position to provide a conclusive statement.From today's perspective we can say that the instrument is working within specifications and speculate that the antibodies are present in too low concentration and can only be partially detected by the solidscreen ii method.The root cause analysis is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false negative respectively weaker antibody screening results with biotestcell 3 on tango infinity.The customer stated that they were running a correlation study with tango infinity, an instrument of a competitor (echo) and in the manual tube method with an enhancement medium.He stated that in four cases, the reactions on tango infinity were false negative respectively weaker positive than expected.The specificity of the affected antibodies was anti-fy(a), anti-k and twice an anti-jk(a).The customer returned neither the supposedly defective product for investigational testing nor the specimens that caused false negative test results.At the time the customer filed his complaint, the supposedly defective lot biotestcell 3 was already expired.Therefore the retention sample could not be tested in our quality control laboratory.Due to the fact that the supposedly defective product was expired and no patient samples are available, an investigation could not be carried out.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Regarding the affected tango infinity, the result images were reviewed and the negative reactions can be confirmed also visually.In some cases there were beginning reactions, indicated as +/- by result interpretation software meaning the reaction is boarderline.The metrology qualification procedure was completed with passing results.Dilution studies were performed using the solidscreen ii qc positive control.The results were as expected.In some cases there was a "?" interpreted result for a strong positive reaction.This phenomenon is known and can be addressed by installing the sp4 upgrade.The log files did not show any issue relevant abnormalities.In accordance to our sop, the instrument related complaint will be closed as undetermined, because no indication for an instrument malfunction could be identified.The service engineer confirmed a proper function of the instrument by metrology qualification.As to the database, no problems with quality control testing on solidscreen ii occurred.Since the samples were not available, we can only speculate that the antibodies were present in too low concentration and are boarderline to be detected by the solidscreen ii method.Also, the customer uses different methods, which are not comparable, such as the tube technique with peg enhancement.The instruction for use contains the following statement: negative reactions can occur in samples with excessively low antibody concentration because this test method cannot detect them.No test method can detect all blood group antibodies.

• Brand Name: TANGO INFINITY
• 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: 8163493
• Report Number: 9610824-2018-00090
• Device Sequence Number: 16463620
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BK150327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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 Model Number: 850000010
• Device Catalogue Number: 850000010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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: ABSD3 LOT # 8812030; ABSD3 LOT # 8812030; AHG, LOT # 874007005; AHG, LOT # 874007005; BIOTESTCELL 3, LOT # 883902100; BIOTESTCELL 3, LOT # 883902100; MLB LOT # 880109100; MLB LOT # 880109100