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

Catalog Number	850000010
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
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 reactions of positive controls with anti-human-globulin, anti-igg solidscreen ii on one of their tango infinity instruments.The same control passed on their other tango infinity instrument.The customer stated that the antibody screening test with biotestcell 1&2 and the weak d testing with solidscreen ii anti-d blend were affected.A sample of the affected product was requested from the customer as well as further information.Our quality control laboratory has not yet started testing their retention sample of the affected product but is waiting for the complaint material the customer announced to send in for investigational testing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Instrument data and log files of the affected tango infinity have been requested and received.Our technical support is still waiting for some requested information in order to be able to analyze the instrument data.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false negative reactions of positive controls with anti-human-globulin, anti-igg solid screen ii on one of their tango infinity instruments.The same control passed on their other tango infinity instrument.The customer stated that the antibody screening test with biotest cell 1&2 and the weak testing with solid screen ii anti-d blend were affected.The customer provided tango infinity screenshots which showed negative reactions with biotestcell 1&2 and solidscreen ii anti-d blend.The screenshots also showed that the negative results were flagged, either as "control failed" or as "discrepant result".The customer neither provided a sample of the allegedly defective product for investigational testing nor the controls which showed false negatives.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot, controls, known antibodies and biotestcell 1&2 on tango infinity.All positive and negative reactions were correct.We did not observe any false negative reaction.Additionally, the retention sample of the ahg anti-igg solidscreen ii was tested for potency and met the acceptance criterion.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Instrument data and log files of the affected tango infinity instrument were provided but were not complete.The analyzis of the available instrument data didn't show any indication of an instrument failure which may lead to the false negative reaction of positive quality control with anti-human-globulin, anti-igg solidscreen ii.The data showed an error message regarding the anti-d blend bottle: reagent bottle overfilled.The cause for this is unknown and therefore it is unsure if this is linked to the complained issue.Based on the investigation the complaint was classified as undetermined.The complaint sample was not available for investigation and the retention sample reacted as expected.The analyze of the available instrument data didn't show any indication of an instrument failure which could lead to the false negative reaction of positive quality control with anti-human-globulin, anti-igg solidscreen ii, but not all requested data were provided.Due to the lack of data and reagents, further investigations were not possible, and the cause of the customer's false negative reactions remained unclarified.

• Brand Name: TANGO INFINITY
• Common Device Name: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 17852296
• Report Number: 9610824-2023-00055
• Device Sequence Number: 6830591
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: BK150327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 850000010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AHG ANTI-IGG SOLIDSCREEN II, LOT 9218130-02; AHG ANTI-IGG SOLIDSCREEN II, LOT 9218130-02
• Patient Sex: Unknown