MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT E3+ CARTRIDGE

Catalog Number	03P82-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.The investigation was completed on 07/17/2017.Retain and return product was tested and was performing to specification.Investigation: a review of the device history record confirmed the lot passed finished goods release criteria.Retain and return cartridge testing met the acceptance criteria found in q04.01.003 rev.Aa, appendix 1 - product complaint level 2 and level 3 investigation procedure.Assessment: the two i-stat results on the same sample are consistent.A different sample was tested on the laboratory instrument and was not tested on the i-stat.The complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.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 e3+ cartridges that yielded suspected discrepant na results on a patient.No patient information was provided.Testing performed on (b)(6)2017.(b)(6).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 E3+ CARTRIDGE
• Common Device Name: E3+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6941392
• Report Number: 2245578-2017-00577
• Device Sequence Number: 872980
• Product Code: JGS
• UDI-Device Identifier: 10054749000101
• UDI-Public: 10054749000101
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K912387
• 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: 11/28/2017
• Device Catalogue Number: 03P82-25
• Device Lot Number: J16344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• 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