MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT PT/INR CARTRIDGE

Catalog Number 03P89-24

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

Patient Problem No Information (3190)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 11/11/2015.Retain and return product was tested and found to be functioning according to specification.Investigation: a review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Cartridge testing of pt/inr cartridge lot t15168b met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.W (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for pt/inr cartridge lot t15168b.Assessment: pt/inr is monitored over time and any changes to medication would be based on the patient history and dietary information.There is not enough information to determine whether an i-stat product malfunction occurred.The complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.

Event Description

On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on a (b)(6) male patient.There was no additional patient information available at the time of this report.(b)(6).At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc; however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care ((b)(4)).

• Brand Name: I-STAT PT/INR CARTRIDGE
• Type of Device: PT/INR CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 6932448
• MDR Text Key: 90178120
• Report Number: 2245578-2017-00391
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2017

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: 12/14/2015
• Device Catalogue Number: 03P89-24
• Device Lot Number: T15168B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 125