MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CREA 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 03/28/2023

Event Type  malfunction  

Event Description

On 29-mar-2023, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine results on a 75 year old male patient presented for a 6 month cancer follow up.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The investigation is underway.

Manufacturer Narrative

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

Event Description

Na.

Manufacturer Narrative

Apoc incident: # (b)(4).The investigation was completed on 19-apr-2023.The customer reported unexpected high creatinine results when comparing the i-stat analyzer to the result from a lab analyzer.An mdr was filed on 11-apr-2023 based on the data available at the time.On 12-apr-2023, the customer emailed to confirm that the patient's oncologist verified patient to be on hydroxyurea.The investigation for this incident was opened on 18-apr-2023.As per artwork 765791-00 rev.B rev.Date 06-mar-2020, i-stat crea cartridge, hydroxyurea is a known interferent where the i-stat creatinine results will be increased.The recommendation is to use another method.Product functioning according to specification and direction.

• Brand Name: I-STAT CREA CARTRIDGE
• Type of Device: CREA+ 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: 16716841
• MDR Text Key: 313590540
• Report Number: 2245578-2023-00034
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Catalogue Number: 03P84-25
• Device Lot Number: A23007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2023
• 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