MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-K; SERACLONE® ANTI-K (KEL1); 5 ML

Catalog Number	808090100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2016
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 the positive control with seraclone anti-k.Customer used a kell positive screening red blood cell as a positive control.The customer returned the supposedly defective product for investigational testing, but not the positive control.Our quality control laboratory tested the seraclone anti-k sample returned by the customer in parallel to their retained product sample.Kell positive and negative screening and panel red blood cells as well as donor red blood cells were used for positive and negative specificity.All positive and negative reactions were correct.We did not observe any false negative results.Both, the complaint and the retained sample were tested for potency.The required minimum titer was exceeded.Testing by our quality control laboratory confirmed that the allegedly defective lot of seraclone anti-k 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-K
• Common Device Name: SERACLONE® ANTI-K (KEL1); 5 ML
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6140448
• Report Number: 9610824-2016-00081
• Device Sequence Number: 323236
• Product Code: KSZ
• UDI-Device Identifier: 07611969951574
• UDI-Public: 07611969951574
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/02/2016

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: 06/02/2017
• Device Catalogue Number: 808090100
• Device Lot Number: 8550050-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 12/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOTESTCELL 3, LOT 8639011-00, EXP. 11/21/2016