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 Hemorrhage/Bleeding (1888)

Event Date 09/14/2020

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) 2020, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result of 3.1 on a (b)(6)- year old female patient with a nose bleed in er the night prior.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method: date: collected: tested: pt/inr: i-stat; (b)(6) 2020; 0720; ni; ni/3.1.Lab; (b)(6) 2020; 0726; ni; 50.9/4.5.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 (b)(6) 2020.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained cartridge testing of pt/inr cartridge lot s20139b met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Af (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
• MDR Report Key: 10635228
• MDR Text Key: 210035303
• Report Number: 2245578-2020-00106
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 10054749000170
• UDI-Public: 10054749000170
• Combination Product (y/n): N
• PMA/PMN Number: K020355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2020
• Device Catalogue Number: 03P89-24
• Device Lot Number: T20184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR