MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT DATA EXCHANGER (DE)

Catalog Number 08K46-01

Device Problem Application Program Problem (2880)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 07/19/2017.The customers reported that after upgrading the i-stat/de system to version 2.8, the reference ranges, actions ranges, and customer reportable ranges for all analytes were reset to default values; however, the preference unique identifier remained the same.This is an unexpected behavior of the i-stat/de system as the reference ranges, action ranges, and customer reportable ranges for all analytes are expected to remain the same as before the upgrade, and the preference unique identifier is expected to change whenever there is a change to any configuration setting in the analyzer's customization preferences.Testing performed at apoc, (b)(4), was able to reproduce the customers' complaint, which was attributed to an issue with the database upgrade utility included with the i-stat/de system version 2.8 installer.A deficiency has been identified.Exception report (er) (b)(4).Has been initiated to address the issue.

Event Description

On (b)(6) 2017, abbott point of care was contacted by a customer who stated that following the update to de 2.8 all critical values have reverted to zeros.There are no injuries associated with this event.Note: the i-stat data exchange (de) system is not a medical device.

• Brand Name: I-STAT DATA EXCHANGER (DE)
• Type of Device: DATA EXCHANGER (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 ; 6136885949
• MDR Report Key: 6785767
• MDR Text Key: 84324853
• Report Number: 2245578-2017-00274
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08K46-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1