MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE

Catalog Number 09P31-26

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

Patient Problems Pneumonia (2011); Renal Failure (2041); Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Failure (2484)

Event Date 03/24/2024

Event Type  malfunction  

Event Description

On 28-mar-2024, abbott point of care (apoc) was contacted by a customer regarding i-stat chem8+ cartridge that yielded discrepant potassium results on an 71 year old female patient with respiratory failure due to pneumonia, copd, complicated by ards & acute renal failure.There was no additional patient information at the time of this report.Return product is not available for investigation.Method date tested k+(mmol/l) bun(mg/dl) crea(mg/dl) i-stat (b)(6) 2024 22:42 5.2 60 2.5 piccolo (b)(6) 2024 22:43 6.7 ni 1.8 i-stat (b)(6) 2024 02:31 5.2 73 2.6 piccolo (b)(6) 2024 02:34 6.7 ni 2.4 at this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggested that product was not performing within the variability.The investigation is underway.

Manufacturer Narrative

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

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 22-may-2024.A review of the device history record (dhr) confirmed the cartridge lot met finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.An, appendix 1 - product complaint level 2 and level 3 investigation procedure.A previously identified unrelated deficiency has been determined for chem8+ cartridge lot h23316 and is being addressed under quality record (qr) (b)(4).

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Type of Device: CHEM8+ 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 ; 6136123525
• MDR Report Key: 19027315
• MDR Text Key: 340120825
• Report Number: 2245578-2024-00072
• Device Sequence Number: 1
• Product Code: JPI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183680NA
• 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: 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2024
• Device Catalogue Number: 09P31-26
• Device Lot Number: H23303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2023
• 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: 71 YR
• Patient Sex: Male