MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT ACT CELITE CARTRIDGE

Catalog Number	03P86-25
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	05/11/2023
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) 2022, abbott point of care was contacted by a customer regarding act celite cartridges that yielded quality check code 44 on a patient during surgery.There was no additional patient information available at the time of this report.Return product is available for investigation.The customer states that on (b)(6) 2023, quality check code 44 (qcc 44) occurred multiple times on a patient during a procedure with multiple analyzers.Other cases running the same day with different patients and using the same cartridge lot functioned as expected.Per doctor, a heparin bolus and drip were started, with serial monitoring of acts to keep act between 350-400 seconds.Qcc 44 occurred and unable to obtain an i-stat act result.A second analyzer was used, and qcc 44 occurred.The catheter was moved from the left into the right.Three analyzers and 8 cartridges were used but qcc 44 persisted.After speaking with the lab and abbott it was confirmed that the analyzers were working, and this was likely a hematologic process.With the inability to go back left sided given safety and risk of cva, the doctor again attempted the vom.They were able to cannulate it with a wire but not the guide catheter.At this time, end tidal co2 was above 50 and doctor decided to terminate the procedure.Although there is no evidence an adverse event occurred, it was determined that a potential delay had occurred.The procedure was canceled for the patient's safety, as it appeared the patient was having an elective surgery and there were no reports of injury to the patient.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 intended use of the i-stat celite activated clotting time (celite act) test is an in vitro diagnostic test that uses fresh, whole blood, and is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant, and dialysis.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 25-jul-2023.A review of the device history record (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.Ak (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.

• Brand Name: I-STAT ACT CELITE CARTRIDGE
• Common Device Name: ACT CELITE CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540
• 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: 17001713
• Report Number: 2245578-2023-00061
• Device Sequence Number: 12336223
• Product Code: JBP
• UDI-Device Identifier: 10054749000149
• UDI-Public: 10054749000149
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K992571
• 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): 07/25/2023

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: 08/31/2023
• Device Catalogue Number: 03P86-25
• Device Lot Number: R23063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2023
• 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 Sex: Unknown