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

Model Number	850000010
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that a patient twice yielded false negative rh(d) results on tango infinity.The customer stated that two different samples of the patient were tested on tango infinity and showed the false negative results.The patient had been tested rh(d) positive on tango optimo in 2020.The rh(d) positive result was now confirmed by another laboratory.We are still waiting for the information which reagents the customer had used on tango infinity.Due to the missing information a testing of the retention sample of the supposedly defective lot was not possible.Also, a review of the batch record documentation was not possible without this information.The customer did also not provide any rsult images for investigation.Log files are not available.The last preventive maintenance was conducted on februar 17, 2021.Further investigations of the affected tango infinity are not possible without further information.We are waiting for additional information, result images, the field service report and log files.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that a patient twice yielded false negative rh(d) results on tango infinity when using erytype s abd+rev.A1, b.The customer stated that two different samples of the patient were tested on tango infinity and showed the false negative results.The patient had been tested rh(d) positive on tango optimo in 2020.The rh(d) positive result was now confirmed by another laboratory.The customer did not send in a sample of the allegedly defective product erytype s abd+rev.A1, b for investigational testing nor a patient sample.Therefore our quality control laboratory tested their retention sample of the supposedly defective lot with different donor samples on tango infinity.All positive and negative reactions were correct.We did not observe any false negative reaction.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 customer provided a black/white result image of poor quality that shows a negative reaction for both anti-d wells.The last preventative maintenance was conducted on march 17, 2021 and the service engineer confirmed a proper function of the instrument.The qc war run and passed all requirements.The log files were provided and did not show any issue relevant abnormalities.The complaint was classified as undetermined because the complaint sample as well as the patient sample were not available, and the retention sample reacted as expected.Due to the missing samples, the negative results at customer´s site remained unknown.Based on current information and data there is no indication for an instrument malfunction.The qc passed at the days of issue.The result was negative for rh(d) in both wells and on both days of testing.The one available result image shows normal negative reactions.The reported problem is likely related to sample specificities.

• 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
• MDR Report Key: 11568145
• Report Number: 9610824-2021-00016
• Device Sequence Number: 3521634
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719(11)180320
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/03/2021
• 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: ERYTYPE S ABD+REV.A1, B, 806127100, LOT 8005120