MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY

Catalog Number 06F16-10

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

Patient Problem No Information (3190)

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 10/05/2016.The analyzer was tested and found to be functioning according to specification.Investigation: the device history record for this analyzer was reviewed.The analyzer passed finished goods release criteria.Fifty pt/inr cartridges were tested using level 1 and level 2 controls, and all results were within the acceptance range.The complaint was not reproduced.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat analyzer is meeting specification.

Event Description

On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on a patient.There was no additional patient information available at the time of this report.(b)(6).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-STAT1 ANALYZER, IMMUNO READY
• Type of Device: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 6932451
• MDR Text Key: 90100205
• Report Number: 2245578-2017-00399
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00054749000340
• UDI-Public: (01)00054749000340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06F16-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1