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 Patient Involvement (2645)
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 a false negative reaction of a jk(a) positive control with seraclone anti-jk(a).The customer used the jk(a) positive panel cell #3 of biotest cell-i11 as a positive control.Despite several inquiries, the customer was not able to provide a date of event.The customer returned the supposedly defective product seraclone anti-jka for investigational testing but he did not return the positive control.Our quality control laboratory tested the complaint sample returned by the customer as well as their retention sample of seraclone anti-jka with different donor cells and reagent red blood cells for potency and specificity.For the specificity testing our quality control laboratory used screening and panel cells of a competitor and also the reagent red blood cells of biotest cell, e.G.Cell #3 of biotest cell-i11.All positive and negative reactions were correct.We did not observe any false negative reaction.The required minimum titer of 8 was exceeded.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-jk(a) 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: 7568361
• Report Number: 9610824-2018-00026
• Device Sequence Number: 1979991
• Product Code: KSZ
• UDI-Device Identifier: 07611969951758
• UDI-Public: (01)07611969951758(17)181014(10)8708030-01
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/05/2018

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: 10/14/2018
• Device Catalogue Number: 808179100
• Device Lot Number: 8708030-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1