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	Intracranial Hemorrhage (1891)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
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 result on a patient.There were no other results presented, no patient information, nor details surrounding the event.Product lot information is also unknown at the time of this report.There return product is not available for investigation.Information has been requested but to no avail.Date: result: (b)(6) 2026, 205; the was no test/collect time for the one result.The customer stated that the "patient ended up having massive cerebral hemorrhage in the recovery room." however, there were no details to the patient's condition, final outcome.Information was requested but to no avail.At this time there is no reason to suspect a malfunction exists.Nor reason to believe the i-stat result of 205 seconds caused or contributed to the event.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.

• 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 ; 400 college road; princeton, NJ 08540-3629 ; 6136885949
• MDR Report Key: 25531410
• Report Number: 2245578-2026-00126
• Device Sequence Number: 9616849
• Product Code: JBP
• UDI-Device Identifier: 10054749000156
• UDI-Public: 10054749000156
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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 Catalogue Number: 03P87-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown