MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-FYA (FY1); SERACLONE ANTI-FYA (FY1)

Catalog Number	808188100
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/18/2018
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 false negative fy(a) antigen typing results when using seraclone anti-fy(a).The customer used various fy(a+b+) positive reagent red blood cells from two different manufacturers.The customer did neither return the supposedly defective product for investigational testing nor the red blood cells that had caused the false negative test result.Therefore our quality control laboratory tested their retention sample with different donor and reagent red blood cells for potency and specificity.For the specificity testing our quality control laboratory used screening and panel cells of a competitor as well as the reagent red blood cells of the biotest cell product line.All positive and negative reactions were correct.We did not observe any false negative reaction.The required minimum titer of 16 was exceeded.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-fy(a) 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: BLOOD GROUPING REAGENT ANTI-FYA (FY1)
• Common Device Name: SERACLONE ANTI-FYA (FY1)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7697405
• Report Number: 9610824-2018-00042
• Device Sequence Number: 906791
• Product Code: KSZ
• UDI-Device Identifier: 07611969951833
• UDI-Public: (01)07611969951833(17)180829(10)8636050-01
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/18/2018

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: 08/29/2018
• Device Catalogue Number: 808188100
• Device Lot Number: 8636050-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1