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

Catalog Number	600-9007-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 04/25/2017.Retain product was tested and functioning according to specification.Return product was not available.Investigation: a review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Z (product complaint level 2 and level 3 investigation procedure).Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.No information is provided regarding sample type, collection device, draw times, test times or test dates.There is not enough information to determine whether an i-stat product malfunction occurred.
Event or Problem Description
On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded high results for chloride and potassium on a patient.There was no patient information at the time of this report.Return product is not available for investigation.(b)(6).Test/collection times are unknown.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc, however this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care ((b)(4)).

• 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: 6941410
• Report Number: 2245578-2017-00581
• Device Sequence Number: 717712
• Product Code: CHL
• UDI-Device Identifier: 10054749000071
• UDI-Public: 10054749000071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/11/2017

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: 02/28/2017
• Device Catalogue Number: 600-9007-25
• Device Lot Number: K16214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1