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 Problems Fever (1858); Respiratory Distress (2045); Chronic Obstructive Pulmonary Disease (COPD) (2237); Chest Tightness/Pressure (2463); Respiratory Failure (2484)

Event Date 02/03/2018

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) 2018, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded suspected discrepant results on a (b)(6) year old female patient with shortness of breath, cough worsening.Patient reported intermittent fevers which have been subjective.(b)(6) nasal congestion.(b)(6) chest tightness.Course/duration of symptoms is constant and worsening.There was no additional patient information available at the time of this report.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Manufacturer Narrative

(b)(4).The investigation was completed on 04/24/2018.A review of the device history record (dhr) confirmed that the cartridge lot passed finished goods release criteria.Retained cartridge test results met the acceptance criteria found in q04.01.003 rev.Ac, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.

• 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
• MDR Report Key: 7404866
• MDR Text Key: 105246312
• Report Number: 2245578-2018-00126
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749002280
• UDI-Public: 10054749002280
• Combination Product (y/n): N
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2018
• Device Catalogue Number: 03P78-50
• Device Lot Number: D17296
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR