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

Model Number 850000010

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported that they missed an anti-d when testing with biotestcell i11 plus on tango infinity.The customer ran a type and screen sample on the tango infinity with biotestcell-3, # (b)(4) and the antibody screen was positive.When performing an antibody identification with biotestcell-i 11 plus, # (b)(4), all panel cells reacted negative.The customer repeated the antibody screen and antibody panel with the tube method and using ortho reagents and in this test the screen cells and the identification panel showed an anti-d.The customer filed his complaint shortly before the allegedly defective product was to expire.Therefor our quality control laboratory already started with testing their the retention samples.Positive and negative controls (e.G.Anti-d) and donor samples were tested on tango infinity.All reactions were correct.Then the antigenicity of the reagent red blood cells was determined in parallel.No distinct differences were found.When this testing was completed, the customer provided the patient sample for investigational testing.But at the time the patient sample arrived on our premises, the allegedly defective product biotestcell i11 plus had already expired.Therefore the patient sample was tested with the current lots of biotestcell-3, # (b)(4) and biotestcell-i 11 plus, # (b)(4) and found to be positive for anti-d.All screen and identification rrbcs with an antigen d reacted strongly positive (3-4).There weren`t any differences between the screen and identification rrbcs particularly with regard to the antigenicity.Testing in our quality control laboratory showed that the allegedly defective lot of biotestcell i11 plus functions correctly.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 was inspected by our field service engineers.Evaluation of the data is still ongoing.

Event Description

The customer reported that they missed an anti-d when testing with biotestcell i11 plus on tango infinity.The customer ran a type and screen sample on the tango infinity with biotestcell-3, #8803021-00 and the antibody screen was positive.When performing an antibody identification with biotestcell-i 11 plus, # 8803011-00, all panel cells reacted negative.The customer repeated the antibody screen and antibody panel with the tube method and using ortho reagents and in this test the screen cells and the identification panel showed an anti-d.The customer filed his complaint shortly before the allegedly defective product was to expire.Therefore our quality control laboratory already started with testing their retention samples.Positive and negative controls (e.G.Anti-d) and donor samples were tested on tango infinity.All reactions were correct.Then the antigenicity of the reagent red blood cells was determined in parallel.No distinct differences were found.Once this testing was completed, the customer provided the patient sample for investigational testing.But at the time the patient sample arrived on our premises, the allegedly defective product biotestcell i11 plus had already expired.Therefore the patient sample was tested with the current lots of biotestcell-3, #8807011-00 and biotestcell-i 11 plus, # 8807011-00 and found to be positive for anti-d.All screen and identification rrbcs with an antigen d reacted strongly positive (3-4).There weren`t any differences between the screen and identification rrbcs particularly with regard to the antigenicity.Testing in our quality control laboratory showed that the allegedly defective lot of biotestcell i11 plus functions correctly.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.There is no indication for a malfunction of the affected tango infinity.

Manufacturer Narrative

This is our final report on this incident.

• 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
• MDR Report Key: 7376759
• MDR Text Key: 104151323
• Report Number: 9610824-2018-00016
• 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: 04/11/2018

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 Model Number: 850000010
• Device Catalogue Number: 850000010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOTESTCELL 3, LOT 8803021-00, EXP. 03/12/18; BIOTESTCELL 3, LOT 8803021-00, EXP. 03/12/18; BIOTESTCELL I11 PLUS,LOT 8803011-00,EXP. 03/12/18; BIOTESTCELL I11 PLUS,LOT 8803011-00,EXP. 03/12/18