MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EC8+ CARTRIDGE

Catalog Number	03P79-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	10/11/2017
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 ec8+ cartridges that yielded a suspected discrepant results on a (b)(6) male patient with chest pain.The patient was transported to the cath lab based on the lab k+ result.There were no clinical decisions made based on the i-stat result.There was no additional patient information at the time of this report.The customer states that return product is not available for investigation.(b)(6).Based on the hct result of <15% along with the suspected discrepant result, hymolosys is there are no injuries associated with this event.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 11/09/2017.Retain product was tested and functioning according to specification.Return product was not available.

• Brand Name: I-STAT EC8+ CARTRIDGE
• Common Device Name: EC8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 7004138
• Report Number: 2245578-2017-00598
• Device Sequence Number: 16440035
• Product Code: CHL
• UDI-Device Identifier: 10054749000071
• UDI-Public: 10054749000071
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 11/17/2017

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: 01/28/2018
• Device Catalogue Number: 03P79-25
• Device Lot Number: K17191
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR