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	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative result of a sample when tested with biotestcell-i11 on tango optimo s/n #(b)(4).The sample was rerun on tango optimo s/n # (b)(4) and yielded correctly positive results with cell #2 and cell #8 of biotestcell-i11.The final result was anti-k.The customer returned neither the supposedly defective product nor the sample that had caused a false negative test result.Therefore our quality control laboratory tested their retained sample of biotestcell-i11 with different samples and controls on tango optimo, including an anti-k.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-i11 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 our field service engineers.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 result of a sample when tested with biotestcell-i11 on tango optimo s/n #(b)(4).The sample was rerun on tango optimo s/n # (b)(4) and yielded correct positive results with cell #2 and cell #8 of biotestcell-i11.The final result was anti-k.The customer returned neither the supposedly defective product nor the sample that had caused a false negative test result.Therefore our quality control laboratory tested their retained sample of biotestcell-i11 with different samples and controls on tango optimo, including an anti-k.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-i11 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 our field service engineers.During this service visit, the wash manifold was replaced.Upon performing preventive maintenance per checklist, the qc runs were passed with acceptable results.The instrument is working within its specifications.

• 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: 6459661
• Report Number: 9610824-2017-00023
• Device Sequence Number: 18973543
• 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,Followup
• Report Date (Section B): 05/22/2017

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: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/22/2017
• 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: BIOTESTCELL 1,2, LOT 8703011-00