MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT CREATININE CARTRIDGE; CREA CARTRIDGE

Catalog Number 03P84-25

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

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) 2024, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine results on a 76 year old male patient with high cholestrol and a renal cyst.There was no patient information available at the time of this report.Return product is not available for investigation.Method date collected tested result sample i-stat on (b)(6) 2024 08:59 08:59 2.1 mg/dl a lab on (b)(6) 2024 09:58 ni 1.5 mg/dl b at this time there is no reason to suspect a malfunction exists.No repoprts of delay or impact to patient management.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.An investigation is underway.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 30-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 crea cartridge lot a23276.

• Brand Name: I-STAT CREATININE CARTRIDGE
• Type of Device: CREA CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road; princeton NJ 08540
• 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 ; 6136123525
• MDR Report Key: 18564879
• MDR Text Key: 333497721
• Report Number: 2245578-2024-00015
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973292
• 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: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 03P84-25
• Device Lot Number: A23276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• 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: 76 YR
• Patient Sex: Male