MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT EG6+ CARTRIDGE

Catalog Number 03P77-25

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

Patient Problems Inflammation (1932); Pain (1994); Septic Shock (2068)

Event Date 10/04/2018

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 (apoc) was contacted by a customer regarding i-stat eg6+ cartridges that yielded a suspected discrepant hemoglobin result on a (b)(6) male patient with epigastric pain x 3 days, and vomiting x3 episodes.There was no additional patient information at the time of this report.Return product is not available for investigation.Method, date, time, hct, hgb.I-stat, (b)(6) 2018, unk, 43%, 14.6 g/dl; lab, (b)(6) 2018, 0538, 26.6%, 8.6 g/dl.Collection times are unknown.There are no injuries associated with this event.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.The investigation is underway.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 11/09/2018.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 EG6+ CARTRIDGE
• Type of Device: EG6+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 8001395
• MDR Text Key: 126371196
• Report Number: 2245578-2018-00265
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 10054749000057
• UDI-Public: 10054749000057
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2019
• Device Catalogue Number: 03P77-25
• Device Lot Number: W18156
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 80 YR