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

Catalog Number 03P85-50

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

Patient Problem No Information (3190)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 11/15/2016.Retain product was tested and functioning according to specification.Return product is not available for investigation.Investigation: a review of the device history record (dhr) confirmed that the cartridge lot met finished goods (fg) release criteria.Retain test results met the acceptance criteria found in q04.01.003 rev.Z appendix 1- product complaint level 2 and level 3 investigation procedure.Customer complaint was not reproduced.Assessment: 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 Description

On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat chem8+ cartridges that yielded suspected discrepant ph result on a (b)(6) male patient.There were no injuries associated with this event.There was no additional patient information available at the time of this report.Return product is not available for investigation.Date: (b)(6) 2016: i-stat - venous blood gases (vbg) 7.451 (ph) taken at 17.56pm / sample drawn and tested immediately, i-stat - arterial blood gases (abg) 7.305 (ph) taken at 18:08pm / sample drawn into syringe and tested immediately.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: 6927076
• MDR Text Key: 89120886
• Report Number: 2245578-2017-00421
• Device Sequence Number: 1
• Product Code: KHP
• UDI-Device Identifier: 10054749001917
• UDI-Public: (01)10054749001917
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Catalogue Number: 03P85-50
• Device Lot Number: D16092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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: 69 YR