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

Catalog Number	850000010
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false negative (or very weak reaction) rh blood typing result with sample no.(b)(6) on their tango infinity instrument.All other results, including daily qc, were within expected results.The sample originated from a maternal advance age woman and is confirmed by a reference lab as a rhd positive and negative for antibody screening.No sample was left to be provided for the investigation.The investigation of the affected tango infinity instrument is still ongoing.
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative (or very weak reaction) rh blood typing result with sample no.(b)(6) on their tango infinity instrument.This result was obtained during the validation of the customer's newly installed ih-500 instrument.All other results, including daily qc, were within expected results.The sample originated from a maternal advance age woman and is confirmed by a reference lab as a rhd positive and negative for antibody screening.The customer stated that all tango infinity qc results were acceptable on the date of event.No sample was left to be provided for the investigation and no trace files were provided for investigation.Given that all other results, including the daily qc, were within expected parameters on that date, this strongly suggests that the reagents were functioning correctly.Therefore, the issue appears to be an isolated event.The affected tango infinity instrument is no longer in service.
Additional Manufacturer Narrative
This is our final report on this incident.

• 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: 22139640
• Report Number: 9610824-2025-00019
• Device Sequence Number: 7122521
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/25/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ERYTYPE S ABD+REV.A1,B, LOT 9441010; ERYTYPE S ABD+REV.A1,B, LOT 9441010
• Patient Sex: Unknown