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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that sporadically, not resuspended artifacts occured in the reverse 0 cells when processing blood typing using erytype s ab0+d and erytypecell on tango optimo.The customer stated that negative reactions in reverse typing looked like there were crumbles in it.These artifacts did cause "+/-" results instead of negative test results on tango optimo just with test cell 0.The customer provided pictures of the phenomenon and did return the supposedly defective product (erytype s ab0+d), erytypecell for investigational testing and also four specimens that had caused that phenomenon.Therefore our quality control tested all complained samples with different donor samples.All positive and negative reactions were correct.We did not observe any false positives or artefacts (crumbles) in reverse typing.Testing by the quality control laboratory confirmed the allegedly defective lot of erytype s ab0+d 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 and was confirmed to work within specifications.At this time the customer did not observe the issue any more.The root cause analysis is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that sporadically, not resuspended artifacts occured in the reverse 0 cells when processing blood typing using erytype s ab0+d and erytypecell on tango optimo.The customer stated that negative reactions in reverse typing looked like there were crumbles in it.These artifacts did cause "+/-" results instead of negative test results on tango optimo just with testcell 0.The customer provided pictures of the phenomenon and did return the supposedly defective product (erytype s ab0+d), erytypecell for investigational testing and also four specimens that had caused that phenomenon.Therefore our quality control tested all complained samples with different donor samples.All positive and negative reactions were correct.We did not observe any false positives or artefacts (crumbles) in reverse typing.Testing by the quality control laboratory confirmed the allegedly defective lot of erytype s ab0+d 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 and was confirmed to work within specifications.The b cell testing well is located prior to the 0 cell well of the corresponding assay.All the patient samples were positive for the b cell.The customer confirmed a proper function of the instrument.Due to the fact that the image evaluation software brought a discrepancy as the forward testing was correctly performed, the customer is prompted reviewing the out coming result in detail.Therefore a false blood typing can be excluded.

• 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: 6861584
• Report Number: 9610824-2017-00069
• Device Sequence Number: 19184414
• 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,Followup
• Report Date (Section B): 10/17/2017

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: 08/16/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1