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

Catalog Number	303467
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PAKAUTO
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 8002478
• Report Number: 2183608-2018-00031
• Device Sequence Number: 1531269
• Product Code: MYP
• UDI-Device Identifier: 10888234500247
• UDI-Public: 10888234500247
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: BK960059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1