MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG6+ CARTRIDGE

Catalog Number 03P77-25

Device Problem False Positive Result (1227)

Patient Problems Chest Pain (1776); Ischemic Heart Disease (2493)

Event Date 09/06/2017

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) 2017, abbott point of care (apoc) was contacted by a customer regarding i-stat eg6+ cartridges that yielded a suspected discrepant result on a (b)(6) male patient with ischemic heart disease and chest pain.The patient was admitted, was still an in-patient as of (b)(6) 2017 and in stable condition.There was no additional patient information at the time of this report.Return product is available for investigation.Method: i-stat, type: arterial, date: (b)(6) 2017, collected: 13:08, tested: 13:08, na: 116 k:2.3, hb: 10.9, hct:32.0; method: i-stat, type: venous, date: (b)(6) 2017, collected: 13:40, tested: 14:05, na: 138, k: 4.0 hb: 11.6, hct:34.4.There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

(b)(4).The investigation was completed on 10/24/2017.Retain and return product was tested and functioning according to specification.

Event Description

Na.

• Brand Name: I-STAT EG6+ CARTRIDGE
• Type of Device: EG6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 6888207
• MDR Text Key: 88228959
• Report Number: 2245578-2017-00305
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000057
• UDI-Public: 10054749000057
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Catalogue Number: 03P77-25
• Device Lot Number: W17107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR