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

Catalog Number	03P87-25
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	07/19/2022
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 kaolin cartridges that yielded a discrepant result of >1000 on a 70 year male patient with chest pain.There was limited information and only one result on initial contact.On (b)(6)2022 new information was reported along with a second result and some patient information.There was no additional information availiable at the time of this report.Return product is not available for investigation.Method date collected tested result sample: i-stat (b)(6)2022 09:44 09:44 249 wb arterial; i-stat (b)(6)2022 11:19 11:19 >1000 wb arterial.Per i-stat system manual (art: 770715-00a), the i-stat kaolin activated clotting time (kaolinact) 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.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information that became available on (b)(6)2022 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 12-oct-2022.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.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 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 ; 6136885949
• MDR Report Key: 15579528
• Report Number: 2245578-2022-00143
• Device Sequence Number: 14998557
• Product Code: JBP
• UDI-Device Identifier: 10054749000156
• UDI-Public: 10054749000156
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/14/2022

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: 10/01/2022
• Device Catalogue Number: 03P87-25
• Device Lot Number: R22094
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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: 70 YR
• Patient Sex: Male