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 Information (3190)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a false negative reaction of a patient sample when tested with seraclone anti-n.The patient had a history of being n antigen positive.The customer provided the supposedly defective product seraclone anti-n for investigational testing and also the patient sample that had caused the false negative test result.The investigation of our quality control laboratory is still ongoing.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Event or Problem Description
The customer reported a false negative reaction of a patient sample when tested with seraclone anti-n.The patient had a history of being n antigen positive.The customer provided the supposedly defective product seraclone anti-n for investigational testing and also the patient sample that had caused the false negative test result.The patient sample was very hemolytic and had to be washed several times.Nevertheless our quality control (qc) laboratory tested the patient sample with the complaint sample returned by the customer and could confirm the customer's finding.The patient sample also yielded a negative result with our qc lab's retention sample and a reference lot.Additionally the patient sample was tested mns system in the id system and yielded also a negative result with anti-n.The patient sample was sent to molecular typing of the n antigen to an external laboratory.The n antigen could be determined, but two other nucleotides were modified.Therefore a n variant was assumed.Until now this variant is not described in the gene data base of blood groups but only in a special project file called 1000g project.The complaint sample returned by the customer as well as the retention sample of seraclone anti-n were tested with different donor and panel samples.All positive and negative reactions were correct.We did not observe any false negative reaction.Due to the false negative reaction of the single patient sample the complaint is confirmed.But according to the molecular typing a n variant is most probably.We will not initiate further actions, because it is a single issue which is related to this specific patient sample.We initiated a bpdr because of the confirmed negative result that was induced by the patient sample.Testing by our quality control laboratory confirmed 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.
Additional Manufacturer Narrative
This is our final report on this incident.

• 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: 7717360
• Report Number: 9610824-2018-00045
• Device Sequence Number: 1108024
• Product Code: KSZ
• UDI-Device Identifier: 07611969952052
• UDI-Public: (01)07611969952052(17)180709(10)8629080-01
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 09/06/2018

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: 07/09/2018
• Device Catalogue Number: 808415100
• Device Lot Number: 8629080-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1