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 Information (3190)
Date of Event	09/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 11/21/2016.Retain and return product was tested and found to be functioning according to specification.Investigation: the device history record for this lot was reviewed.The lot passed finished goods release criteria.Forty retained and 98 returned cartridges were tested using whole blood as well as blood samples which simulate patients undergoing oral anticoagulant therapy.Testing met the acceptance criteria found in q04.01.003 rev z, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lot is meeting specification.
Event or Problem Description
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat act celite cartridges that yielded unexpected results on a patient.There was no additional patient information available at the time of this report.Test time: act: 0943, 551.0954, 211.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc; however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care (b)(4).

• 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: 6932461
• Report Number: 2245578-2017-00377
• Device Sequence Number: 16174203
• Product Code: JBP
• UDI-Device Identifier: 10054749000149
• UDI-Public: 10054749000149
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K992571
• Number of Events Summarized: 1
• Summary Report (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): 10/09/2017

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: 01/28/2017
• Device Catalogue Number: 03P86-25
• Device Lot Number: R16217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1