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

Model Number 850000010

Device Problems False Positive Result (1227); Component Missing (2306); Defective Device (2588)

Patient Problem Reaction (2414)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported false positive reactions in the anti-b wells of erytype s abd+rev.A1, b on tango infinity.The customer stated that samples of the blood group a were affected.The customer has neither returned the sample that had caused false negative test results nor the supposedly defective product for investigational testing.We requested and are still awaiting further information, e.G.The lot number of the supposedly defective product.Due to the missing lot information a testing of the retention sample and the review of the batch record review documentation was so far not possible.Regarding the affected tango infinity: the customer provided result images that show the described phenomenon: the cells in the anti-b well were not completely resuspended and there were spread dark red dots, which lead the instruments image evaluation software to calculate a positive result.Due to the discrepancy between forward and reverse testing, the instrument did not give out an overall blood type result and thus no false result was released.A field service engineer (fse) was several times on-site.Spolv and orbital shaker were replaced and the linear shaker loader aligned, but the problem persisted when patient samples were tested.One week later the issue recurred.Out dated reagents were discarded and samples were re-mixed.Qc passed.The customer left his reagents open for the whole 7 days of use and stored them in fridge uncovered.We have requested and are still waiting for further information, e.G.The log files.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported false positive reactions in the anti-b wells of erytype s abd+rev.A1, b when used on tango infinity.The customer stated that samples of the blood group a were affected.The customer stated that she first observed the issue with her quality control (qc).The lab internal qc3 should be blood group a rhd negative, but she received the result blood group ab.The customer retested the same reagents on another tango infinity and received correct results.Furthermore the customer stated that patient samples were also affected.The customer did neither provide the complaint sample for investigational testing nor the control respectively patient samples that caused false positive test results.But the customer provided tango infinity images which demonstrated the described issue.Due to the discrepancy between forward and reverse testing, the instrument did not give out an overall blood type result and thus no false result was released.Our quality control laboratory tested their retention sample of erytype s abd+rev.A1, b with different donor samples on tango infinity.All positive and negative reactions were correct.We did not observe any false positive reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of erytype s abd+rev.A1, b functions correctly.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 described phenomenon: the cells in the anti-b well are not completely resuspended and there are spread dark red dots, which lead the instruments image evaluation software to calculate a positive result.Due to the discrepancy between forward and reverse testing, the instrument does not give out an overall blood type result and thus no false result is released.The last preventative maintenance date is january 10, 2020.Our field service engineer (fse) was several times on-site.Replacements (unrelated) were done, but the problem persisted when patient samples were tested.Summary of work already performed by fse: spolv and orbital shaker were replaced and linear shaker loader aligned.Next day issue recurred.Started with qc only, but then affected patient samples.Also smaller cell button on p1 in screen.Fse found linear shaker misaligned (loose screws).Alignment fixed problem.One week later issue recurred.Out dated reagents were discarded and samples were re-mixed.Qc passed.Reagents are left open for the whole 7 days of use and stored in fridge uncovered.Copy log files were not made available.The instrument related complaint will be closed as undetermined, because the root cause for false positive results in the anti-b well could not be determined.Additionally, log files, samples and reagents were not made available.The problem did finally not recur after fses followed instructions provided.

• 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
• MDR Report Key: 9659046
• MDR Text Key: 204775649
• Report Number: 9610824-2020-00004
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: (01)07611969961719
• Combination Product (y/n): N
• PMA/PMN Number: BK150327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 850000010
• Device Catalogue Number: 850000010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ERYTYPE S ABD+REV. A1,B, LOT NO. 8906070; ERYTYPE S ABD+REV. A1,B, LOT NO. UNKNOWN