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

Catalog Number	848 900 010
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a (b)(6) result of a patient sample when tested with anti-human-globulin solidscreen ii on tango optimo.The customer returned the patient sample that had caused the (b)(6) test result, but none of the supposedly defective product.Testing of our retained product sample in our quality control laboratory is still ongoing.The affected tango optimo was inspected by one of our field service engineers.We are still waiting for this report.Root cause analysis is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a false negative direct antiglobulin test (dat) of a patient sample when tested with anti-human-globulin solidscreen ii on tango optimo.The customer returned the patient sample that had caused a false negative test result, but none of the supposedly defective product.Upon arrival on our premises the patient sample was very haemolytic.Nevertheless the patient sample was tested with the qc lab's retained sample of anti-human-globulin on tango optimo.The reactions were assessed by tango optimo as being positive.But due to the hemolysis of the patient sample the quantity of red cells was not sufficient to obtain a valid test result.The qc lab's retained product sample was also tested with igg sensitized red cells and showed correct positive reactions.Testing by our quality control laboratory confirmed that the allegedly defective lot of anti-human-globulin, anti-igg solidscreen ii 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 optimo was inspected by one of our field service engineers with no indication for an instrument and/or software malfunction.The instrument was confirmed to operate within specification after engineer intervention for maintenance.Haemolysis of the patient sample made it impossible to evaluate the reaction strength correctly.

• Brand Name: TANGO OPTIMO
• Common Device Name: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6053302
• Report Number: 9610824-2016-00066
• Device Sequence Number: 1838350
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (Y/N): N
• PMA/510(K) Number: BK080013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 848 900 010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 01/09/2017
• 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: AHG SOLIDSCREEN II, LOT 2607080-00; MLB 2, LOT 260310200; SOLIDSCREEN II STRIP, LOT 2625050