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	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false positive test results of a rh negative patient sample when tested on tango optimo.The customer performed the blood typing of the sample on the instrument and yielded a 1+ reaction on rh confirmation.The customer repeated with new segment of the blood unit and they got a 1+ reaction again.The customer repeated the test with new plates, got 1+ again.After running the monthly maintenance, the test was repeated and showed 1+ again.Bench testing (with tube method) yielded a negative result, and the weak d was negative as well.After changing the bromelin, the customer was able to get a negative reaction.All qc tests results were as expected and other patient's results were all consistent.The investigation is still ongoing.
Additional Manufacturer Narrative
This is our initial report on this incident.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false positive test results of a rh negative patient sample when tested on tango optimo.The customer performed the blood typing of the sample on the instrument and yielded a 1+ reaction on rh confirmation.The customer repeated with new segment of the blood unit and they got a 1+ reaction again.The customer repeated the test with new plates, got 1+ again.After running the monthly maintenance, the test was repeated and showed 1+ again.Bench testing (with tube method) yielded a negative result, and the weak d was negative as well.The trace files of the affected tango optimo instrument were analyzed.The analysis showed that all three samples were tested multiple times due to their results fluctuating between negative and positive results.This confirms our believe that the bromelin buffer solution was likely the root cause of the issue raised by the customer.After changing the bromelin, the customer was able to get a negative reaction.All qc tests results were as expected and other patient's results were all consistent.No anomalies were detected during the analysis of the trace files.

• 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: 21272920
• Report Number: 9610824-2025-00003
• Device Sequence Number: 3916555
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/04/2025

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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/04/2025
• 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: BROMELIN, LOT 942807000.; BROMELIN, LOT 942807000.; ERYTYPE S RHD CONFIRM, LOT 9349030.; ERYTYPE S RHD CONFIRM, LOT 9349030.
• Patient Sex: Unknown