MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-D BLEND; SERACLONE ANTI-D BLEND

Catalog Number	802033100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a (b)(6) reaction of a patient sample when tested with (b)(6).When tested a second time, the same patient sample showed a weak positive test result.The customer returned the supposedly defective product and also the patient that had caused the (b)(6) test result.Testing in our quality control laboratory is still ongoing.
Additional Manufacturer Narrative
This is our 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-d blend.When tested a second time, the same patient sample showed a weak positive test result.The customer returned the supposedly defective product and also the patient that had caused the false negative test result.Our quality control laboratory tested the patient sample with the supposedly defective product sample as well as with the qc lab's retained sample and yielded correct strong positive results.Both, complaint and retained sample were also tested with different samples.All positive and negative reactions were correct.We did not observe any false negative reaction.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-d blend 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-D BLEND
• Common Device Name: SERACLONE ANTI-D BLEND
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 5998985
• Report Number: 9610824-2016-00062
• Device Sequence Number: 901961
• Product Code: KSZ
• UDI-Device Identifier: 07611969950201
• UDI-Public: 07611969950201
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/10/2017

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: 07/17/2017
• Device Catalogue Number: 802033100
• Device Lot Number: 8531100-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1