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

Catalog Number	806127100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2017
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 fibrin was present in reverse typing of a few samples with erytype s abd+rev.A1, b on tango optimo.Customer stated that due to the fibrin negative reactions of reverse typing were false positive.The customer returned the supposedly defective product, but not the patient samples that had caused false positives.Our quality control laboratory tested the complaint sample of erytype s abd+rev.A1, b with different donor samples on tango optimo.All positive and negative reactions were correct.Only in one case the negative result in reverse typing was not completely resuspended.Visually assessed it was clearly a negative reaction.Erytype s abd+rev.A1, b is a microtest plate ready for use for abo blood group typing.The wells for the antigen typing (forward testing) contain dried monoclonal antibodies.The wells for the reverse typing do not contain any sera or reagents, the wells are empty.During the processing of the erytype s abd+rev.A1, b, the donor samples and reagent red blood cells are pipetted into the wells of the reverse typing.Red cells of donors and patients are pipetted into the wells for the forward testing.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.

• Brand Name: ERYTYPE S ABD+REV A1,B
• Common Device Name: ERYTYPE S ABD+REV A1,B
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6521573
• Report Number: 9610824-2017-00029
• Device Sequence Number: 19231164
• Product Code: KSZ
• UDI-Device Identifier: 07611969951147
• UDI-Public: 07611969951147
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2017

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 Expiration Date: 02/18/2018
• Device Catalogue Number: 806127100
• Device Lot Number: 8634070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/26/2017
• 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: TANGO OPTIMO, # (B)(4)