MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT G3+ CARTRIDGE

Catalog Number 03P78-50

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

Patient Problem Atherosclerosis (1728)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded a suspected discrepant result on a (b)(6) year old male patient with atherosclerosis.There was no additional patient information at the time of this report.Return product is not available for investigation.(b)(6).There are no injuries associated with this event.The investigation is underway.

Manufacturer Narrative

(b)(4).The investigation was completed on 01/26/2018.Retain product was tested and functioning according to specification.Return product was not available.

• Brand Name: I-STAT G3+ CARTRIDGE
• Type of Device: G3+ 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: 7106857
• MDR Text Key: 94831510
• Report Number: 2245578-2017-00632
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749002280
• UDI-Public: 10054749002280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940918
• 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,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Catalogue Number: 03P78-50
• Device Lot Number: D17224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2017
• 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
• Patient Age: 68 YR