MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. FACTOR VIII ANTIBODY SCREEN

Catalog Number F8S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

A customer complaint was received (cmp-216) which described that the factor viii antibody screen (f8s) assay results were negative (neg) and the laboratory's in-house (b)(6) assay results were positive.The ordering physician was expecting (b)(6) results ( units - bu) and contacted lab when they did not receive the bu results.The laboratories testing paradigm was to test samples on the f8s kit and if positive results (pos) were obtained, then the sample was refluxed to the (b)(6) assay.The initial customer notification was provided to manufacturer on (b)(6 )2014.After multiple requests of customer, samples were sent on (b)(6) 2014 to manufacturer.Internal testing showed that the concerned lot of product was performing as expected when using internal well-characterized samples.The (b)(6) assay is in internal lab developed test.The laboratory has changed their testing paradigm due to this information to reflux samples to the (b)(6) assay if f8s is less than 20 percent activity.

Manufacturer Narrative

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• Brand Name: FACTOR VIII ANTIBODY SCREEN
• Type of Device: FACTOR VIII ANTIBODY SCREEN
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; waukesha WI
• Manufacturer Contact: 20925 crossroads circle; waukesha, WI 53186 ; 2627541009
• MDR Report Key: 3902584
• MDR Text Key: 4543554
• Report Number: 2183608-2014-00001
• Device Sequence Number: 1
• Product Code: GGP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK082205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2015
• Device Catalogue Number: F8S
• Device Lot Number: 3001285
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1