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

Catalog Number 850000010

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

The customer reported false positive reactions in the anti-b of erytype s abd+rev.A1, b when used on tango infinity.The customer stated that the issue occurred sporadically without providing more than one date of event.The customer provided tango images which showed weak positive reactions in the anti-b.The customer did neither provide the complaint sample erytype s abd+rev.A1, b for investigational testing nor the patient samples that had caused the false positive test results.Therefore our quality control laboratory tested their retention sample of the allegedly defective lo with different donor samples on tango infinity.All positive and negative reactions were correct.We did not observe any false positive 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 result images that show weak (1+) positive results in the anti-b well (forward testing) that is discrepant to the reverse testing.The instrument's software marked these results as discrepant, and no false result was released.The positive result occurred due to the dark red button-like spot in the middle of the well and a few agglutinates around that spot.The background is red colored, and it seems like the agglutinates were not well resuspended.The last preventative maintenance was performed on january 25, 2022.One of our field service engineers went onsite and verified that spolv is washing properly.He collected log files for submission and review.During a second visit, he found evidence of splashing on the centrifuge lid and linear shaker.He proceeded to perform alignment from plate stacker through to the centrifuge and ran a qc to verify working order.During a follow-up visit, the field service engineer completed a decontmination of the instrument and fluid containers, rinsed thoroughly and introduced new fluids.During an other follow-up visit, the customer reported improvement on the analyzer from the decontamination.The field service engineer checked and verified wet cell, orbital shaker, and alignments of the system.He found a leak above the stacking area by the plate mover.Replaced tubing in the area.The instrument was found to be within manufacturer means and was returned to the customer for normal use.The initially provided log files were analyzed, and specific instructions were given where an issue could have occurred and might have influenced the false positive results.Further investigation is necessary, but not possible without further information and a new log file set.We are waiting for that additional requested information.Due to the ongoing investigation, we are not in the position to provide a conclusive statement.The root cause analysis is still ongoing.

Manufacturer Narrative

This is our initial report on this incident.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported false positive reactions in the anti-b of erytype s abd+rev.A1, b when used on tango infinity.The customer stated that the issue occurred sporadically without providing more than one date of event.The customer provided tango images which showed weak positive reactions in the anti-b.The customer did neither provide the complaint sample erytype s abd+rev.A1, b for investigational testing nor the patient sample that had caused the false positive test result.Therefore our quality control laboratory tested their retention sample of the allegedly defective lot with different donor samples on tango infinity.All positive and negative reactions were correct.We did not observe any false positive 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 result images that show weak (1+) positive results in the anti-b well (forward testing) that is discrepant to the reverse testing.The instrument's software marked these results as discrepant, and no false result was released.The positive result occurred due to the dark red button-like spot in the middle of the well and a few agglutinates around that spot.The background is red colored, and it seems like the agglutinates were not well resuspended.The last preventative maintenance was performed on (b)(6) 2022.One of our field service engineers went onsite and verified that spolv is washing properly.He collected log files for submission and review.During a second visit, he found evidence of splashing on the centrifuge lid and linear shaker.He proceeded to perform alignment from plate stacker through to the centrifuge and ran a qc to verify working order.During a follow-up visit, the field service engineer completed a decontmination of the instrument and fluid containers, rinsed thoroughly and introduced new fluids.One week after the visit where the instrument and the fluid containers were decontaminated, our field service engineer was again on site to verify if the decontamination solved the issue.The customer reported improvement on the analyzer from the decontamination.The field service engineer checked and verified wet cell, orbital shaker, and alignments of the system.He found a leak above the stacking area by the plate mover and replaced tubing in the area.Potential drops from that leak did not fall into any strips, so that this could not have caused the weak positive reaction.Also, the tube wasone of the so-called waste hoses, which remove waste and thus also could not contribute to a reaction in the well.The instrument was found to be within manufacturer means and was returned to the customer for normal use.Based on the images provided the complaint was classified as confirmed - upp (unexpected product performance).A product sample of erytype s abd+rev.A1,b was not available for investigation and the retention sample reacted as expected.A general issue could be excluded, because the retention sample reacted as expected and we did not receive any other complaints about this issue.From the affected instrument's perspective, based on current information there is no indication for an instrument malfunction.No false result was released because the discrepancy was identified by the instruments software.The engineer confirmed that the instrument is working within specification after his latest service visit.Most likely the decontamination did resolve the problem.The customer was advised to be aware of performing the maintenance procedure described in the user manual correctly.Our initial report on this incident was submitted for the erytype s abd+rev.A1,b strip.During our investigation, we could not find any evidence that the erytype plate caused the incident but a contamination of the tango instruments might have contributed to it.So this final report is filed for the instrument, not for the erytype strip.

• Brand Name: TANGO INFINITY
• Type of Device: 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: 13415648
• MDR Text Key: 287663813
• Report Number: 9610824-2022-00001
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)220814(10)9107070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Catalogue Number: 850000010
• Device Lot Number: 9107070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ERYTYPE S ABD+REV. A1,B LOT 9107070; TANGO INFINITY, SN (B)(4)