MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT CTNL CARTRIDGES; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Lot Number C17063

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Chest Pain (1776); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969)

Event Date 07/13/2017

Event Type  malfunction  

Event Description

I stat troponin cartridge error x 2 for 1 rn.I stat troponin cartridge error on third attempt by second rn.4th attempt by third rn was successful.Patient arrived in emergency department (ed) with chest pain/suspected myocardial infarction (mi).Md ordered a bedside troponin level.When troponin bedside test was attempted, rn received "cartridge error" message from istat machine so he attempted the troponin test with a second cartridge.The same message appeared for the second cartridge.Patients blood was redrawn and a third cartridge was attempted.Third cartridge attempt with redraw of patients blood stated "cartridge error" again.Fourth cartridge attempted and was successful.Patients troponin was elevated.Cartridge error x 3 delayed proper and important patient care.

• Brand Name: I-STAT CTNL CARTRIDGES
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road east; princeton NJ 08540
• MDR Report Key: 7048476
• MDR Text Key: 92657742
• Report Number: 7048476
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/28/2017
• Device Lot Number: C17063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR