MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG8+ CARTRIDGE

Catalog Number 03P88-25

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Chest Pain (1776)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant hematocrit results on a (b)(6) male patient with chest pain.There was no patient information available at the time of this report.The patient was transfused based on the sysmex and i-stat results.There were no injuries reported.Return product is available for investigation.(b)(6).Sample collect times were not provided.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 12/10/2018.A review of the device history record confirmed the lot passed finished goods release criteria.Retain cartridge test results met the acceptance criteria found in q04.01.003 rev.Ac, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.

• Brand Name: I-STAT CG8+ CARTRIDGE
• Type of Device: CG8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8023529
• MDR Text Key: 125915557
• Report Number: 2245578-2018-00271
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (y/n): N
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2019
• Device Catalogue Number: 03P88-25
• Device Lot Number: W18222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR