MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT ACT KAOLIN CARTRIDGE

Catalog Number	03P87-25
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	12/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 30-dec-2024, abbott point of care was contacted by a customer regarding i-stat act kaolin cartridges that yielded a discrepant results on a patient.There was no patient information available.Return product is available for investigation.Method act comment i-stat >700 sec there was no overdosing of the patient i-stat >1000 sec no additional heparin being administered i-stat >1000 sec no baseline testing.No patient information, no test/collection times, no heparin dose/time.It is unknown if protamine was administered.No product lot# information.Information requested but not provided.At this time there is no reason to suspect a malfunction exists.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.Per i-stat system manual (art: 714185-00q), the i-stat kaolin activated clotting time (kaolin act) test is an in vitro diagnostic test that uses fresh, whole blood.And is used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).Additional information: a2 & b7.The investigation was completed on 06-mar-2025.A review of the device history record (dhr) confirmed the cartridge lot passed release specifications.Retained cartridge testing met the acceptance criteria in appendix 1 of q04.01.003 rev.An (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.
Event or Problem Description
Na.

• Brand Name: I-STAT ACT KAOLIN CARTRIDGE
• Common Device Name: ACT KAOLIN CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 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 ; 6136885949
• MDR Report Key: 21090952
• Report Number: 2245578-2025-00003
• Device Sequence Number: 20991782
• Product Code: JBP
• UDI-Device Identifier: 10054749000156
• UDI-Public: 10054749000156
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K023582
• 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): 03/10/2025

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: 02/24/2025
• Device Catalogue Number: 03P87-25
• Device Lot Number: R24221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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: 63 YR
• Patient Sex: Male