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 09/18/2023

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 (b)(6) 2023, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine result of 404 umol/l on a patient.There was no patient information available at the time of this report.Method result i-stat 404 umol/l.Lab 64 umol/l.Customer did not provide test/collection times, dates, nor details surround the event.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.Two i-stat results are consistently high on two different samples.It is suspected based on the elevated i-stat results that the patient may be on hydroxyurea and the cause for the elevated results.However, there was no confirmation of the patient's medications at the time of this report.The investigation is underway.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 18-oct-2023.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Al, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.

Event Description

Na.

• 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: 17911868
• MDR Text Key: 325381359
• Report Number: 2245578-2023-00138
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2023
• Device Catalogue Number: 03P84-25
• Device Lot Number: A23137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• 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