MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. PAK12

Catalog Number PAK12

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/31/2015

Event Type  malfunction  

Event Description

Five customer complaints were received ((b)(4)) describing pak12 lot 3002648 is generating invalid assays due to high negative control values.Per the pak12 ifu, the average negative control values for the gpiib/iiia rows must be

• Brand Name: PAK12
• Type of Device: PAK12
• 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: julie ewend ; 20925 crossroads circle; waukesha, WI 53186 ; 2627541009
• MDR Report Key: 5078641
• MDR Text Key: 26322445
• Report Number: 2183608-2015-00002
• Device Sequence Number: 1
• Product Code: MYP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: BK950004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2016
• Device Catalogue Number: PAK12
• Device Lot Number: 3002648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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