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

Catalog Number	03P77-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	Chest Pain (1776); Ischemic Heart Disease (2493)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).The investigation was completed on 10/24/2017.Retain and return product was tested and functioning according to specification.
Event or Problem Description
Na.

• Brand Name: I-STAT EG6+ CARTRIDGE
• Common Device Name: EG6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6888207
• Report Number: 2245578-2017-00305
• Device Sequence Number: 760917
• Product Code: CHL
• UDI-Device Identifier: 10054749000057
• UDI-Public: 10054749000057
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K940918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR