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 Consequences Or Impact To Patient (2199)
Date of Event	07/11/2017
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 a patient sample yielded a false negative result with biotestcell-p3 on tango optimo, (b)(4).Two other tango optimo instruments yielded a positive result with this sample.The customer did neither return the supposedly defective product nor the patient samples that had caused false negative test results.Therefore our quality control laboratory tested their biotestcell-p3 retention sample with different antibodies and controls (including anti-d,-c,-e,-fya,-jka, k).Additional a titration of solidscreen ii control (anti-d) was performed.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed the correct functionality of the allegedly defective lot of biotestcell-p3.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 confirmed to run within specifications.The log files did not show any issue relevant abnormalities on the dates of testing.But it was recognized that the sample was first loaded on this instrument at 10:31 on (b)(6) 2017 indicating the same sample tube was loaded -other than reported- three times on the instrument.Then an active rack was removed from the instrument, which is not allowed.

• 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: 6770009
• Report Number: 9610824-2017-00051
• Device Sequence Number: 16528703
• Product Code: KSZ
• UDI-Device Identifier: 07611969961696
• UDI-Public: 07611969961696
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/07/2017

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1