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

Catalog Number	03P84-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
Na.
Additional 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
• Common Device Name: 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
• Report Number: 2245578-2023-00034
• Device Sequence Number: 1614783
• Product Code: CGL
• UDI-Device Identifier: 10054749000125
• UDI-Public: 10054749000125
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: US
• PMA/510(K) Number: K973292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male