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

Catalog Number 808052100

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

The customer reported a false negative result of seraclone anti-s with one heterozygous panel cell of a competitor.The customer did return the supposedly defective product, but not the panel cell that had caused the false negative test result.Our quality control laboratory tested the allegedly defective seraclone anti-s sample with different panel cells of bio-rad and a competitor.All positive reactions were correct.We did not observe any false negative or weakened reactions.Furthermore, a potency testing of the complaint seraclone anti-s sample was performed in parallel to the retained sample of seraclone anti-s.The required minimum titer was exceeded in both cases.Complaint and retained sample yielded comparable reactions.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.

Manufacturer Narrative

This is our combined initial and final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT ANTI-S (MNS3)
• Type of Device: SERACLONE ANTI-S (MNS3)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• Manufacturer (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 6330 3; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303 ; 1033130576
• MDR Report Key: 3662086
• MDR Text Key: 22000861
• Report Number: 9610824-2014-00008
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/06/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2015
• Device Catalogue Number: 808052100
• Device Lot Number: 8326080-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ORTHO PANEL, BATCH UNKNOWN; IMMUCOR PANEL, LOT 49147