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 Patient Involvement (2645)
Date of Event	02/08/2018
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 stated that when testing blood grouping reagent seraclone anti-n, the negative control yielded an unexpected positive reaction.The customer used ortho gel reagent red cells for qc.The customer did not provide the supposedly defective product for investigational testing.Therefore our quality control laboratory tested six different reagent red blood cells of the antigen constellation mmss with their retention sample of seraclone anti-n.Five reagent red blood cells yielded correctly negative result, but one reagent red blood cell showed a weakly (+/-) positive reaction.Additionally the retention sample of seraclone anti-n was tested with additional five donor samples (3 x mmss, mmss, mmss).All reactions were correctly negative.Furthermore ph value was measured and potency was tested.The retention sample met all acceptance criteria.Due to the single very weak (+/-) false positive reaction the findings of the customer were confirmed but only by using reagent red blood cells of the antigen constellation mmss.Very weak nonspecific reactions with seraclone anti-n were found in our qc tests only if the red cells had the phenotype mmss, meaning n antigen negative cells with double-dose expression (homozygous) of the s antigen.The approximate frequency of this phenotype is only 6% in caucasians.The unspecific reactions with blood grouping reagent anti-n were only sporadically observed in samples of this phenotype.Due to the fact that the antibody is usually not clinically relevant, will not be detected with usual test methods including 37°c incubation and the low phenotype frequency, the risk of a possible delay (antibody identification in patients and/or antigen testing of red blood cell concentrates) is negligible.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: 7372705
• Report Number: 9610824-2018-00014
• Device Sequence Number: 1146460
• Product Code: KSZ
• UDI-Device Identifier: 07611969952052
• UDI-Public: (01)07611969952052(17)180709(10)8629080-01
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 03/27/2018

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1