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 Atrial Fibrillation (1729); Fall (1848); Head Injury (1879); High Blood Pressure/ Hypertension (1908); Lymphoma (3263)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant results on a (b)(6) female patient with atrial fibrillation, blunt head trauma right forehead s/p mechanical fall.There was no additional patient information at the time of this report.Return product is available.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on 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 09/05/2018.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained cartridge testing of pt/inr cartridge lot t18109a met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure).Returned cartridge testing of pt/inr cartridge lot t18109a was unable to reproduce the customer's observation of unexpected results.No deficiency has been identified for pt/inr cartridge lot t18109a.

• 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: 7738420
• MDR Text Key: 115658952
• Report Number: 2245578-2018-00193
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2018
• Device Catalogue Number: 03P89-24
• Device Lot Number: T18109A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR