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 Codes	Aortic Valve Stenosis (1717); Dyspnea (1816)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # 845281 apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2020, abbott point of care was contacted by a customer regarding act celite cartridges that yielded a result of >1000 on an (b)(6) year old female patient presented for a transaortic valve replacement.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on 02-feb-2021.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained and returned cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Af (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
• MDR Report Key: 10859694
• Report Number: 2245578-2020-00123
• Device Sequence Number: 16794513
• Product Code: JBP
• UDI-Device Identifier: 10054749000149
• UDI-Public: 10054749000149
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/08/2021

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: 12/04/2020
• Device Catalogue Number: 03P86-25
• Device Lot Number: R20159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR