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	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false negative reactions of jk(a+) red blood cells when tested with seraclone anti-jk(a).The customer returned the supposedly defective product for investigational testing but not the specimens that caused the false negative reactions.Testing in 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.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false negative reactions of jk(a+) red blood cells with blood grouping reagent seraclone anti-jka (jk1).The customer stated that they use jka+ panel cells as positive control.The customer could not provide the information which panel red blood cells were used for testing (manufacturer unknown).The customer returned two vials of the supposedly defective product seraclone anti-jka for investigational testing but not the panel cells that had caused false negative test results.Additionally the customer returned two vials each of blood grouping reagent anti-jk(a) lot #8729070-01 and lot #8742050-01.Our quality control laboratory tested the customer's seraclone anti-jka complaint sample as well as the retention samples of all three lots.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 donor red blood cells and panel cells of two different manufacturers.Strong positive reactions were yielded with all jka+ red blood cells and panel cells.In summary all three batches reacted comparable.All results of qc testing were conclusive.No weakening and discrepant results were observed and all acceptance criteria were fulfilled.The complaint of the customer could not be confirmed.Testing in our quality control laboratory demonstrated that the complaint sample of blood grouping reagent seraclone 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: 7424307
• Report Number: 9610824-2018-00017
• Device Sequence Number: 19161198
• Product Code: KSZ
• UDI-Device Identifier: 07611969951758
• UDI-Public: (01)07611969951758(17)180611(10)8642050-01
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 06/13/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1