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

Catalog Number	03P89-24
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident #: (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On 19-jan-2023, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant inr result of 2.9 on a patient.There was no patient information available at the time of this report.Return product is available for investigation.Method : i-stat, date: 18-jan-2023, result (units): 2.9; method : lab, date: 18-jan-2023, result (units): 0.99.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.The customer reports that the patient is not on oral anticoagulant (coumadin or warfarin) therapy.As per prothrombin time, pt/inr ifu art: 715236-00s.The customer was advised of off label use and the intended use for the i-stat pt/inr.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.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 29-mar-2023.A review of the device history record (dhr) confirmed the cartridge lot passed release specifications.Retained cartridge testing met the acceptance criteria in appendix 1 of q04.01.003 rev.Ak (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.

• Brand Name: I-STAT PT/INR CARTRIDGE
• Common Device Name: 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 ; 6136885949
• MDR Report Key: 16232912
• Report Number: 2245578-2023-00012
• Device Sequence Number: 6870855
• Product Code: GJS
• UDI-Device Identifier: 10054749000170
• UDI-Public: 10054749000170
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K020355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: Health Professional
• Device Expiration Date: 03/21/2023
• Device Catalogue Number: 03P89-24
• Device Lot Number: T22265A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown