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 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

This is a known malfunction with the precision link software that can lead to incorrect trending of results.This occurs when results, obtained on a meter with incorrect date and time, are uploaded to a computer with precision link software.Customers and retailers have been notified through the (b)(6) letter.The device manufacturer date for the suspect device is unknown.The date entered in section is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Caller reported not being able to set the date and time on their adc glucose meter and they reported to be a user of the precision link data management system.There was no report of death, serious injury or mistreatment associated with this event.

Manufacturer Narrative

This serves as a correction report.(b)(4) was modified from (b)(4) to (b)(4).

Event Description

Caller reported not being able to set the date and time on their adc glucose meter and they reported to be 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: 7650961
• MDR Text Key: 112754456
• Report Number: 2954323-2018-04904
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• 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