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 Problems High Blood Pressure/ Hypertension (1908); Pneumonia (2011); Renal Failure (2041); Gastroesophageal Burn (4475)

Event Date 12/31/2023

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 02-jan-2024, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridge that yielded a suspected discrepant po2 result on a 185 mmhg on a 63 year old male patient with end-stage chronic renal failure on regular dialysis, type 2 diabetes, hypertension, pneumonia , lipid disorders, and gastroesophageal reflux.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method date tested po2 so2 sample i-stat (b)(6) 223 0949 25 mmhg 40% a i-stat (b)(6) 223 ni 185 mmhg 99.6 b 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 the limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 31-jan-2024.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Al (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for cg4+ cartridge lot m23227.

• 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 ; 185 corkstown road; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6133123525
• MDR Report Key: 18521352
• MDR Text Key: 332953498
• Report Number: 2245578-2024-00010
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2024
• Device Catalogue Number: 03P85-25
• Device Lot Number: M23227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2023
• 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: 64 YR
• Patient Sex: Male