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

Catalog Number	848 900 010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported that she missed an anti-e and anti-k when using biotestcell 1&2 on tango optimo sn #(b)(4).Both samples were reran on tango optimo sn #(b)(4) and yielded correctly positive results.The customer returned neither the supposedly defective product biotestcell 1&2 nor the samples that had caused false negative test results.Therefore our quality control laboratory tested their retention sample of biotestcell 1&2 with samples and controls, e.G.Anti-e and anti-k of proficiency testing on tango optimo.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of biotestcell 1&2 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.The wash manifold was cleaned and the needle alignments verified.A qc run that was performed after this invention showed good results.The patient sample was run and the instrument was able to detect the antibody.System performance was validated and found to run within manufacturers specification.

• Brand Name: AUTOMATED BLOOD BANK ANALYSER SYSTEM
• Common Device Name: TANGO OPTIMO
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6685534
• Report Number: 9610824-2017-00043
• Device Sequence Number: 16157479
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 07/05/2017

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): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1