MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-N (MNS2); SERACLONE ANTI-N (MNS2)

Catalog Number	808415100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2017
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 a false negative reaction of a reagent red blood cell of a competitor when testing with seraclone anti-n.The customer used two different lots of seraclone anti-n.The customer provided the supposedly defective product lot 8629080-01 and also the reagent red blood cell of the competitor for investigational testing.At the time our quality control laboratory received the reagent red blood cell it was already expired.Therefore our quality control laboratory tested the complaint sample as well as their retention samples of both affected lots with different red blood cells for potency and specificity.The required minimum titer of 4 was exceeded.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-n 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-N (MNS2)
• Common Device Name: SERACLONE ANTI-N (MNS2)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6953980
• Report Number: 9610824-2017-00075
• Device Sequence Number: 16475102
• Product Code: KSZ
• UDI-Device Identifier: 07611969952052
• UDI-Public: 07611969952052
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/17/2017

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: 10/29/2018
• Device Catalogue Number: 808415100
• Device Lot Number: 8645080-01
• 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: 09/19/2017
• Initial Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1