MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPECELL A1 & B; ERYTYPECELL A1 & B, 2X10 ML

Catalog Number	816056100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
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 questionable results in reverse typing (+/- on the b cells) when using erytypecell a1&b o tango optimo.Sometimes the +/- reactions occurred on the a1 cells as well.With a fresh set of a1 and b cells this issue has not occured anymore.The customer did not provide the erytypecell a1&b that had caused +/- reactions on their tango optimo for investigational testing.The customer did also not provide the requested images of the +/- reactions.The complained rrbc´s erytypecell a1&b were used within qc testing in our quality control laboratory with different samples on tango optimo.No irregularities were found.The negative reactions were clearly negative.Testing by our quality control laboratory confirmed that the allegedly defective lot erytypecell 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.Data of the involved tango optimo were analyzed with no indication for an instrument malfunction.

• Brand Name: ERYTYPECELL A1 & B
• Common Device Name: ERYTYPECELL A1 & B, 2X10 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7617973
• Report Number: 9610824-2018-00035
• Device Sequence Number: 1818429
• Product Code: KSZ
• UDI-Device Identifier: 07611969952656
• UDI-Public: (01)07611969952656(17)180604(10)8815011-00
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/20/2018

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: 06/04/2018
• Device Catalogue Number: 816056100
• Device Lot Number: 8815011-00
• 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: 05/24/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1