MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT 6+ CARTRIDGE

Catalog Number	03P80-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/18/2016
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 04/13/2016.Retain and product was tested and functioning according to specification.Return product was not available for investigation.Investigation: the customer reported obtaining an unexpected k+ result while using 6+ cartridge lot k15261a to test a patient sample.The device history record (dhr) for this lot was reviewed.The lot passed finished goods (fg) release criteria.Forty retained cartridges from the lot were tested using whole blood (wb) and i-stat level 1 control (l1).Testing met the acceptance criteria found in q04.01.003 rev.X, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.No repeats on the i-stat or laboratory.
Event or Problem Description
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded suspected discrepant potassium (k) result on a patient.There was no patient information available at the time of this report.Results from (b)(6) 2015: i-stat k+ - 2.1, antech k+ - 4.3.There was no additional patient information available at the time of this report.Return product is not available for investigation.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 6+ CARTRIDGE
• Common Device Name: 6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 6932269
• Report Number: 2245578-2017-00331
• Device Sequence Number: 1324020
• Product Code: JGS
• UDI-Device Identifier: 10054749000088
• UDI-Public: 10054749000088
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/09/2017

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: No Information
• Device Expiration Date: 06/14/2016
• Device Catalogue Number: 03P80-25
• Device Lot Number: K15261A
• 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: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1