MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B; ERYTYPE S ABD+A1,B

Catalog Number	806127100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
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 (b)(6) was typed as blood group ab in the forward testing and typed as blood group a in the reverse typing.The customer used erytype s abd+rev.A1,b on tango optimo.The customer did not return the supposedly defective product erytye s abd+rev.A1,b for investigational testing but the patient sample.Therefore our quality control laboratory tested their retention sample of erytype s abd+rev.A1, b with the patient sample on tango optimo.Sample (b)(6) yielded blood group a rh(d) positive.The correctness of the typed blood group of the sample was additionally confirmed in the gel card method.In all tests of quality control laboratory the forward and the reverse typing of the patient sample matched.We did not observe any discrepancies between forward and reverse typing.Additionally our qc lab's retention sample of erytype s abd+rev.A1,b was tested with different donor samples.All positive and negative reactions were correct.We did not observe any false positive respectively false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of erytype s abd+rev.A1, b 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 checked by one of our field service engineers and found to be running within specifications.

• Brand Name: ERYTYPE S ABD+REV A1,B
• Common Device Name: ERYTYPE S ABD+A1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7676750
• Report Number: 9610824-2018-00041
• Device Sequence Number: 920966
• Product Code: KSZ
• UDI-Device Identifier: 07611969951147
• UDI-Public: (01)07611969951147(17)180324(10)8739110
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: 03/24/2018
• Device Catalogue Number: 806127100
• Device Lot Number: 8739110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1