MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG4+ CARTRIDGE

Catalog Number 03P85-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 09/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 11/25/2015.Retain product was tested and functioning according to specification.Return product was not available for investigation.Investigation: 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 a whole blood (wb) sample and i-stat tricontrols level 1 control (l1).The customer complaint was not reproduced.Testing met the acceptance criteria found in q04.01.003 rev.W, 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.

Event Description

On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges that yielded suspected discrepant ph and pc02 results on a patient.There was no additional patient information available at the time of this report.Return product is not available for investigation.A patient sample was tested on (b)(6) 2015 with following results: ph = 6.88, pco2 = >17 kpa; the result was queried by the doctor and the sample was repeated in the lab: ph = 7.0, pco2 = 8; customer has run other samples since then with no unexpected results.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 CG4+ CARTRIDGE
• Type of Device: CG4+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 6932280
• MDR Text Key: 90242161
• Report Number: 2245578-2017-00337
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 10054749000132
• UDI-Public: 10054749000132
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K982071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Catalogue Number: 03P85-25
• Device Lot Number: M15065A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1