MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. PAK12G

Catalog Number PAK12G

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/01/2016

Event Type  Death  

Event Description

Customer complaint ((b)(4)) received on (b)(6) 2017.Reported death after antibody screening.Antibody screening was performed with maipa and pak12g.

Event Description

Mdr follow-up to correct date of event, date of report, and date received.

• Brand Name: PAK12G
• Type of Device: PAK12G
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• Manufacturer (Section G): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• Manufacturer Contact: joan rixe ; 20925 crossroads circle; waukesha, WI 53186-4054 ; 2627541016
• MDR Report Key: 6494828
• MDR Text Key: 72911911
• Report Number: 2183608-2017-00001
• Device Sequence Number: 1
• Product Code: MYP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK930032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2017
• Device Catalogue Number: PAK12G
• Device Lot Number: 3004690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2017
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death