MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT®/DE SOFTWARE; I-STAT DE

Catalog Number 08K46-01

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

Details were provided with the action that was conducted in cooperation with the u.S.Food and drug administration apoc product action number: (b)(4).Product name: list number: part number: primary version : version: qualifier, udi.I-stat®/de software , 08k46-01, 115200, 047659-01, 2.8 , n/a, 00054749001255.

Event Description

A remedial action has been completed to provide recommendations to the customer for product in the field.I-stat/de is a software product which facilitates the administration of the i-stat 1 system through data manager software sold by third party vendors, or by abbott point of care.Abbott point of care inc.(apoc) has determined through investigation of customer complaints that the reference ranges, action ranges and customer reportable ranges for all analytes are reset to default values after upgrading to version 2.8.Additionally, location, operator, and patient lists stored in the i-stat 1 handheld will not update after upgrading to i-stat/de version 2.8 from an earlier version.No erroneous results are generated on the i-stat handheld as a result of this issue.It is important to note that any customized ranges (reference, action and reportable) will be reset to factory default.Patient results are accessible in the i-stat handheld and all of the associated information there is correct.Additionally, all measured or calculated parameters performed by the i-stat handheld remain accurate and are not impacted.There have not been any injuries associated with this issue.Two mdrs have been filed with fda.There has not been any adverse event or adverse reaction reports filed.

• Brand Name: I-STAT®/DE SOFTWARE
• Type of Device: I-STAT DE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540-3629 ; 6136885949
• MDR Report Key: 6833877
• MDR Text Key: 84326854
• Report Number: 2245578-2017-00281
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/31/2017

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
• Device Operator: No Information
• Device Catalogue Number: 08K46-01
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: APOC2017-005
• Patient Sequence Number: 1