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

Catalog Number 850000010

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2017

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported a discrepant result when testing the product ahg igg scii on tango infinity # (b)(4) and tango infinity sn (b)(4).A known positive sample showed a 2+ positive reaction on tango infinity # s/n (b)(4) whereas the same sample showed a negative reaction when tested on sn (b)(4).The customer returned the supposedly defective product ahg igg sc ii and a bottle of mlb2 for investigational testing.The sample that had caused false negative test result was not available.Therefore our quality control laboratory tested the supposedly defective product anti-human-globulin, anti-igg solidscreen ii in comparison with the retained lot of this product.The complained reagent showed functionality as expected.Furthermore dat testing was carried out in parallel on two instruments.Therefore dat positive samples were tested on tango infinity and on tango optimo by using the complained reagent from the customer in parallel to the retained sample.All results were comparable and showed clearly positive reactions.Testing by our quality control laboratory confirmed the correct functionality of the allegedly defective lot of anti-human-globulin, anti-igg solidscreen ii.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango infinity (b)(4) was inspected by one of our field service engineers by performing metrology qualification procedure as required.At this time a cause for an instrument malfunction could not be identified, the evaluation of further data is still ongoing.

Manufacturer Narrative

This is our final report on this incident.

Event Description

The customer reported a discrepant result when testing the product ahg igg scii on tango infinity #(b)(4) and tango infinity sn #(b)(4).A known posiitve sample showed a 2+ positive reaction on tango inifinity # s/n (b)(4) whereas the same sample showed a negative reaction when tested on sn # (b)(4).The customer returned the supposedly defective product ahg igg sc ii and a bottle of mlb2 for investigational testing.The sample that had caused false negative test result was not available.Therefore our quality control laboratory tested the supposedly defective product anti-human-globulin, anti-igg solidscreen ii in comparision with the retained lot of this product.The complained reagent showed functionality as expected.Furthermore dat testing was carried out in parallel on two instruments.Therefore dat positive samples were tested on tango infinity and on tango optimo by using the complained reagent from the customer in parallel to the retained sample.All results were comparable and showed clearly positive reactions.Testing by our quality control laboratory confirmed the correct functionality of the allegedly defective lot of anti-human-globulin, anti-igg solidscreen ii.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The affected tango infinity # (b)(4) was inspected by one of our field service engineers.All points and checks passed.Also multiple dat testing of patient sample in question was done with similar positive results on both instruments.After performing post service verification procedure as required the instrument was confirmed to operate within specification.The customer stated that the problem did not return images of the reported false negative result were not saved and could not be found by customer.Other delivered images from both instruments are showing positive dat results as expected.The initially reported false negative result was observed one time which gave a weak result by tube testing.The tango infinity is not validated for cord blood samples.No indication for an instrument malfunction could be identified.The instrument is working within specifications.

• Brand Name: TANGO INFINITY
• Type of Device: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6864346
• MDR Text Key: 87321557
• Report Number: 9610824-2017-00070
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969961719
• UDI-Public: 07611969961719
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 850000010
• Device Lot Number: 4230000129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 09/26/2017
• 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: TANGO INFINITY #423000136; TANGO INFINITY #423000136