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

Catalog Number 303467

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/02/2018

Event Type  malfunction  

Event Description

(b)(6) 2018.The customer returned kit from lot 3006837 (pa) was tested in parallel with an immucor-wks retention kit from lot 3006837 (pa) on (b)(6) 2018.The customer returned kit and the retention kit from lot 3006837 (pa) gave negative control od average values in the iib/iiia rows that did not meet ifu validity criteria.The negative serum control is run in duplicate with each test run.The negative serum control should give an average od value of < or equal to 0.160 od in the iib/iiia rows.The customer complaint ((b)(4)) was reproduced.The customer was performing validation and study testing using the kit.Corrective action is being taken through fa-wks-18-008, to notify customers of the affected pakauto lot.

• Brand Name: PAKAUTO
• Type of Device: PAKAUTO
• 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: robert voigts ; 20925 crossroads circle; waukesha, WI 53186 ; 2627541006
• MDR Report Key: 8002478
• MDR Text Key: 125774863
• Report Number: 2183608-2018-00031
• Device Sequence Number: 1
• Product Code: MYP
• UDI-Device Identifier: 10888234500247
• UDI-Public: 10888234500247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK960059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/15/2019
• Device Catalogue Number: 303467
• Device Lot Number: 3006837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1