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 Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant inr results a 78 year old female patient with a history of deep vein thrombosis and pulmonary embolism.There was no additional patient information available at the time of this report.Return product is available for investigation.Method date collected tested inr sample i-stat: (b)(6) 2023, 02:52, 02:52, 3.7, whole blood- a.Stago: (b)(6) 2023, 03:32, ni, 2.5, plasma- b.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.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.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 15-aug-2023.A review of the device history record (dhr) confirmed the cartridge lot passed release specifications.Retained cartridge testing of pt/inr cartridge lot t23054 did not meet the acceptance criteria in appendix 1 of q04.01.003 rev.Al (product complaint level 2 and level 3 investigation procedure) for points outside allowable error (ea).Returned cartridge testing meets the acceptance criteria in appendix 1 of q04.01.003 rev.Al (product complaint level 2 and level 3 investigation procedure).A deficiency has been identified for pt/inr cartridge lot t23054.Pt/inr cartridge lot t23054 has been added to quality record (qr) (b)(4) to address the root cause.

• 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 ; 185 corkstown road; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6136123525
• MDR Report Key: 17126518
• MDR Text Key: 317680453
• Report Number: 2245578-2023-00067
• 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,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2023
• Device Catalogue Number: 03P89-24
• Device Lot Number: T23054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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: 78 YR
• Patient Sex: Female