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	Test Result (2695)
Date of Event	03/08/2019
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 donor unit when tested with seraclone anti-jk(a).The customer stated that she had to crossmatch a patient with a known anti-jk(a).The donor unit was typed for jk(a) using seraclone anti-jk(a).The donor unit yielded a negative reaction.Based on this negative reaction the donor unit was crossmatched for the patient.But the crossmatch was found to be incompatible.The donor unit was retested internally and externally and found to be jk(a) positive.The customer did neither return the supposedly defective product seraclone anti-jka for investigational testing nor the donor unit that caused the false negative test result.Therefore our quality control laboratory tested their retention sample of seraclone anti-jka with different donor and reagent red blood cells for potency and specificity.For the specificity testing our quality control laboratory also used panel cells of a competitor.All positive and negative reactions were correct.We did not observe any false negative reaction.The potency testing was done with donor red blood cells.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: 8486009
• Report Number: 9610824-2019-00011
• Device Sequence Number: 1019063
• Product Code: KSZ
• UDI-Device Identifier: 07611969951758
• UDI-Public: (01)07611969951758(17)190929(10)8806030-01
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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: 09/29/2019
• Device Catalogue Number: 808179100
• Device Lot Number: 8806030-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1