MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. PRECISION LINK; DATA MANAGEMENT SYSTEM

Model Number 97443

Device Problem Computer Software Problem (1112)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

This is a known malfunction with the precision link software that can lead to incorrect trending results.This occurs when results, obtained on a meter with incorrect data and time, are uploaded to a computer with precision link software.Customers and retailers have been notified through the adc (b)(4) letter.The device manufacturer date is unknown.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the date and time are incorrectly displayed on their adc blood glucose built in meter.It was then additionally identified by adc customer service that the customer is a user of the precision link data management system.There was no report of death, serious injury or mistreatment associated with this event.

• Brand Name: PRECISION LINK
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 7601319
• MDR Text Key: 111403249
• Report Number: 2954323-2018-04456
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• PMA/PMN Number: K952279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/14/2018

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: Lay User/Patient
• Device Model Number: 97443
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-0709-2007
• Patient Sequence Number: 1