MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT ACT KAOLIN CARTRIDGE; 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	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, abbott point of care was contacted by a customer regarding i-stat act kaolin cartridges that yielded a discrepant results on a 51-year-old male patient with atrial fibrillation.There was no additional patient information available.Return product is not available for investigation.Date : tested result: heparin time: on (b)(6) 2026, 16000, 9:44, (b)(6) 2026, 10:00, >1000, (b)(6) 2026, 10:27, 286 , (b)(6) 2026, 10:27, 276 , (b)(6) 2026 , 3000 , 10:30.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).The customer reported unexpected results when testing cartridges from act kaolin cartridge lot# r25236.The customer returned lot# r25326 for investigation.Although both lots had been used at the facility, based on event date, lot# r25326 would be the lot in use at the time of the event.Lot# r25236 would have been expired.The investigation was completed on 06-may-2026.A review of the device history records (dhr) confirmed the cartridge lot passed release specifications.Retained and returned cartridge testing met the acceptance criteria in appendix 1 of q04.01.003 rev.Ap (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for lot# r25326.(refer to d4 & h4 for corrected information).
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: 24579409
• Report Number: 2245578-2026-00053
• Device Sequence Number: 13351070
• Product Code: JBP
• UDI-Device Identifier: 10054749000156
• UDI-Public: 10054749000156
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 05/13/2026

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: 05/21/2026
• Device Catalogue Number: 03P87-25
• Device Lot Number: R25326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2025
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 105 KG