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 06/26/2020

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 2.5 on a (b)(6) year old female patient.The customer stated the patient came in with a mild cardio issue.Testing was performed to monitor the patient inr.The patient was not on coumadin or warfarin.There was no patient information available at the time of this report.Return product is not available for investigation.Method: i-stat, date: (b)(6) 2020, collected: 14:29, tested: 14:29, inr: 2.5.Lab/acl top, (b)(6) 2020, 14:33, 15:13, 1.0.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 patient is not on coumadin/warfarin and product was being used outside its intended use.The i-stat® pt/inr test is a whole blood determination of the prothrombin time used for monitoring oral anticoagulant (coumadin or warfarin) therapy.Reference cti sheet: prothrombin time pt/inr art: (b)(4).The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 08/13/2020.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.Af (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
• MDR Report Key: 10271264
• MDR Text Key: 198863953
• Report Number: 2245578-2020-00076
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Catalogue Number: 03P89-24
• Device Lot Number: S20055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR