MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-S (MNS3); SERACLONE® ANTI-S (MNS3); 2ML

Catalog Number	808052100
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial and final report on this incident.
Event or Problem Description
The customer reported false negative reactions of two donor segments with a history of anti-s when tested with seraclone anti-s.The customer did not provide the supposedly defective product nor the donor segments that had caused the false negative results.Therefore our quality control laboratory tested the retention sample for potency and specificity.All positive and negative reactions were correct.We did not observe any false negative reaction.The minimum titer was exceeded.Testing by our quality control laboratory confirmed the allegedly defective lot of seraclone anti-s 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-S (MNS3)
• Common Device Name: SERACLONE® ANTI-S (MNS3); 2ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7463642
• Report Number: 9610824-2018-00022
• Device Sequence Number: 145016
• Product Code: KSZ
• UDI-Device Identifier: 07611969951536
• UDI-Public: (01)07611969951536(17)190228(10)8710130-01
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2018

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: 02/28/2019
• Device Catalogue Number: 808052100
• Device Lot Number: 8710130-01
• 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: 03/30/2018
• Initial Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1