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	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident (b)(4).Additional lot: r22331, expiration date: (b)(6)2023, mfg date: (b)(6) 2022.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 (lots r22331 and r23009) that yielded discrepant results on a patient receiving open heart surgery.There was no additional patient information available at the time of this report.Return product is available for investigation.The customer reported that the i-stat 1 system did not give results for act and gave back-to-back quality check codes 6 times while patient was on the operating table with heart bypassed during surgery.No act results were able to be obtained from the i-stat 1 system leading to a delay in proceeding with the next steps during surgery.Although quality check codes are part of the i-stat system, it was determined that a significant delay occurred during the event.The customer states that the facility was able to use an alternative method (hemochron) to get act results and proceed with the surgery.There was no impact to patient management.Facility reports the patient is in good condition after the surgery.Refer to art: 714260-00z, analyzer coded messages code number: qcc 44 cause/action message on display: unable to position sample/ use another cartridge explanation: the analyzer did not detect movement of sample across the sensors.This could be due to a clot in the sample (especially in neonates), to not closing the snap closure on the cartridge, or to an aberrant cartridge.Code number: qcc 46 cause/action message on display: cartridge error/ use another cartridge explanation: the analyzer did not detect movement of sample across the sensors.This could be due to a clot in the sample (especially in neonates), to not closing the snap closure on the cartridge, or to an aberrant cartridge.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.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.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 24-may-2023.A review of the device history records (dhrs) confirmed the cartridge lots 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: 16677782
• Report Number: 2245578-2023-00029
• Device Sequence Number: 5219896
• Product Code: JBP
• UDI-Device Identifier: 10054749000149
• UDI-Public: 10054749000149
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/25/2023

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: 07/08/2023
• Device Catalogue Number: 03P86-25
• Device Lot Number: R23009
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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