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	08/14/2016
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 jk(a) positive samples with seraclone anti-jk(a).The customer also reported that she was not sure which reactions were positive respectively negative.The incidents occured on (b)(6), for which we filed a separate mdr, on (b)(6) (this mdr) and also some day during "the last week of (b)(6)".Since we do not know the exact date for the event in july, we refrained from filing a separate report.The customer returned the supposedly defective product seraclone anti-jka and also seven patient samples that had caused unclear test results.Our quality control laboratory tested the patient samples with the customer's returned seraclone anti-jka sample and also with their retained product sample.Six patient samples showed clearly positive results and one sample reacted negatively.Additionally, the returned and the retained seraclone anti-jka sample were tested with different jka+b+ red blood cells.All positive reactions were correct.We did not observe any false negative reaction.The potency of the retained and the complaint sample were also tested.The required minimum titer was exceeded.Complaint and retained sample showed comparable results in all tests.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: 5955221
• Report Number: 9610824-2016-00060
• Device Sequence Number: 39944
• Product Code: KSZ
• UDI-Device Identifier: 07611969951758
• UDI-Public: 07611969951758
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/16/2016

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: 01/22/2017
• Device Catalogue Number: 808179100
• Device Lot Number: 8523040-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2016
• Initial Report FDA Received Date: 09/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1