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	12/09/2016
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 donor unit when tested with seraclone anti-jk(a).We are still waiting for the supposedly defective product for investigational testing and also for the donor unit that had caused a false negative test result.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a false negative reaction of a donor unit when tested with seraclone anti-jk(a).The customer returned the supposedly defective product for investigational testing , but did not return the sample that had caused a false negative test result.Our quality control laboratory tested the returned product sample in comparison to their retained seraclone anti-jka sample with different jka+b+ red blood cells.All positive reactions could be confirmed as correct, no false negative reactions were observed.A potency test of the retained and the complaint sample showed comparable results, both samples exceeded the required minimum titer.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: 6249429
• Report Number: 9610824-2016-00099
• Device Sequence Number: 19048799
• Product Code: KSZ
• UDI-Device Identifier: 07611969951758
• UDI-Public: 07611969951758
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/16/2017

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: 10/07/2017
• Device Catalogue Number: 808179100
• Device Lot Number: 8607050-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1