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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  malfunction  

Event Description

On 02-feb-2023, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant inr results a 63 year old female patient with deep vein thrombosis.There was no additional nformation available at the time of this report.Return product is available for investigation.Method date collected tested results (sec) sample i-stat (b)(6) 2024 11:46 11:50 *>8 5 acl top (b)(6) 2024 12:50 13:50 4.1 6 at this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.Pt/inr - intended use the i-stat pt, a prothrombin time test, is useful for monitoring patients receiving oral anticoagulation therapy such as coumadin ® or warfarin.

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Manufacturer Narrative

Apoc incident: (b)(4).The investigation was completed on 09-apr-2024.A review of the device history record (dhr) confirmed the cartridge lot passed release specifications.Retained and returned cartridge testing met the acceptance criteria in appendix 1 of q04.01.003 rev.An (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.

• 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; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136123525
• MDR Report Key: 18696283
• MDR Text Key: 335259509
• Report Number: 2245578-2024-00021
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P89-24
• Device Lot Number: F23323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2023
• 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: 63 YR
• Patient Sex: Female