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 01/09/2020

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 results 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: (b)(6) 2020, tested: 1310, pt / inr: ni / 3.3.I-stat, (b)(6) 2020, 1316, ni / 2.2.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 04/01/2020.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ae (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.

Event Description

Na.

• 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: 9642570
• MDR Text Key: 198878387
• Report Number: 2245578-2020-00020
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2020
• Device Catalogue Number: 03P89-24
• Device Lot Number: S19269
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1