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 Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Pain (1994); Respiratory Failure (2484)

Event Date 08/27/2019

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) 2019, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result of 47.3/4.2 on a (b)(6) year old male that arrived at the hospital intubated; non responsive and with an active gi bleed.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).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 customer states that the patient is not on coumadin or warfarin.It was determined that the customer is not using i-stat pt/inr for its intended use.Per 715236-00s, the i-stat pt, a prothrombin time test, is useful for monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.The customer also stated that the patient received fresh frozen plasma based on the i-stat result.Based on the information given that patient may have been unnecessarily transfused.This is an adverse event.The investigation is underway.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 09/25/2019.A review of the device history record confirmed that the cartridge lot passed release specifications.Retained and returned cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ad (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: 9077647
• MDR Text Key: 169918735
• Report Number: 2245578-2019-00218
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2019
• Device Catalogue Number: 03P89-24
• Device Lot Number: S19183A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR