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	06/09/2018
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 patient sample when tested with seraclone anti-jk(a).The customer returned the supposedly defective product for investigational testing and also the patient sample that had caused the false negative test result.Our quality control laboratory tested the complaint sample as well as their retention sample of seraclone anti-jk(a) with the patient sample and yielded a positive result.Additionally the supposedly defective product was tested for specificity and potency.All acceptance criteria were met.The required minimum titer of 8 was exceeded.We did not observe any false negative reaction.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.A handlings failure of customer cannot be excluded, because in the test protocols submitted by the customer an incubation temperature of 37°c is documented.According to the instruction for use tests with seraclone anti-jk(a) have to be incubated at room temperature and not at 37°c.

• 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: 7672673
• Report Number: 9610824-2018-00037
• Device Sequence Number: 1383992
• Product Code: KSZ
• UDI-Device Identifier: 07611969951758
• UDI-Public: (01)07611969951758(17)190310(10)8729070-01
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/10/2018

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: 03/10/2019
• Device Catalogue Number: 808179100
• Device Lot Number: 8729070-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1