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

Catalog Number	808179100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
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 reported that they had very weak reactions with the positive control when using our blood grouping reagent seraclone anti-jka (jk1), lot 8642050-01.They had discrepant results between two lot numbers with a donor sample.With a "new" lot of anti-jka (jk1), #8729070-01, they got a 2+ pos.Reaction and the result with the "old" (#8642050-01) lot was negative.The bottle with the allegedly defective product had been discarded by the customer.But the customer provided a patient sample and an aliquot of the quotient panel cell that were used for testing.Our quality control laboratory tested their retention samples of both reagent lots that were used on the customer's site.The potency was checked as well as the positive and negative specificity.The minimum potency of 1:8 was exceeded.The positive and negative specificity was tested with erythrocytes from donors.The quotient panel cell was also used and the patient sample sent in by the customer that had caused discrepant results.Our quality control laboratory yielded a 4w positive reaction with the patient sample with both batches.The quotient panel cell was used "washed out" and suspended 5% with isotonic saline solution and "ready for use".By incubation for 15 min.At room temperature the reactions were 4+ pos.And the reactions incubated for 30 min.Were 2+ pos.For the "ready for use" panel cell.The same test approach using the "washed out" panel cell from quotient yielded a 3+ pos.Reaction.Additionally we found out, that the agglutinates of the "ready for use" ortho panel cell were not as solid as the "washed out" panel cell.In summary both batches reacted comparable.The results of qc testing were all conclusive.No weakening and discrepant results were observed and all acceptance criteria were fulfilled.Testing in our quality control laboratory confirmed that the complained reagent of blood grouping reagent anti-jka (jk1) 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-JK(A)
• Common Device Name: SERACLONE ANTI-JK(A)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 7372687
• Report Number: 9610824-2018-00015
• Device Sequence Number: 1007076
• Product Code: KSZ
• UDI-Device Identifier: 07611969951758
• UDI-Public: (01)07611969951758(17)180611(10)8642050-01
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 06/11/2018
• Device Catalogue Number: 808179100
• Device Lot Number: 8642050-01
• 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: 02/28/2018
• 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