MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS BIOTESTCELL 1,2

Catalog Number	816014100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2018
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 reaction of two patient samples with biotestcell 3 when used on tango optimo.The specificity of the missed antibodies was anti-e.The antibodies were detected with the enhancement medium polyethylene glycol (peg).The customer said to send in the supposedly defective product for investigational testing and also the patient samples that had caused a false negative test result.Our quality control laboratory has not received them so far.
Additional Manufacturer Narrative
This is our fnal report on this incident.
Event or Problem Description
The customer initially reported a false negative reaction of two patient samples with biotestcell 3 when used on tango optimo.The specificity of the missed antibodies was anti-e.The antibodies were detected with the enhancement medium polyethylene glycol (peg).When the complaint was investigated it became clear that the false negative reaction happened when testing with biotestcell 1,2 and not with biotestcell 3.Our initial report stated biotest 3 as the affected product.This has been corrected in this final report.The customer sent in the two patient samples that had caused discrepant test results for investigational testing but not the supposedly defective product.Our quality control laboratory tested their retained sample of biotestcell 1,2 with different samples and controls on tango optimo.No irregularities were found.The patient samples were also tested.The reactions were visually negative and the tango optimo evaluated them as negative.Additionally, the patient samples were tested with biotestcell i11, # (b)(6) and also yielded negative results.Our quality control laboratory tested the patient samples on tango optimo with enzyme treated rrbc´s (biotestcell-p3 e).The reactions were 3 + and 2 + positive for anti-e.This result was also verified by testing using the gel method.The test results strongly suggest that the patient samples have a very weak expression of antibody anti-e, or rather the detection is only possible by using enzyme (e.G.Peg).We would like to refer to the product's instructions for use (ifu): "negative reactions will be obtained if the sample contains antibodies present in concentrations too low to be detected by the test method"."no test method is capable of detecting all red cell antibodies".Testing by our quality control laboratory confirmed the correct function of the allegedly defective lot biotestcell 1,2.The observed results may be present due to sample specificity.No indication for an instrument malfunction could be identified.As the negative results were observed on three different tango optimo instruments, the issue is highly likely not related to instruments performance.As to preventive maintenance report the reported instrument was confirmed to operate in specification.

• Brand Name: REAGENT RED BLOOD CELLS BIOTESTCELL 1,2
• Common Device Name: BIOTESTCELL 1,2
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7322847
• Report Number: 9610824-2018-00013
• Device Sequence Number: 16551627
• Product Code: KSZ
• UDI-Device Identifier: 07611969952687
• UDI-Public: (01)07611969952687(17)180312(10)8803011-00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/21/2018

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 Expiration Date: 03/12/2018
• Device Catalogue Number: 816014100
• Device Lot Number: 8803011-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 03/21/2018
• 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: TANGO OPTIMO, # (B)(4); TANGO OPTIMO, # (B)(4)