MAUDE Adverse Event Report: PRODIGY DIABETES CARE LLC PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM; GLUCOSE OXIDASE, GLUCOSE

Model Number PRODIGY VOICE

Device Problems Computer Software Problem (1112); Problem with Software Installation (3013)

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

Event Date 07/03/2017

Event Type  malfunction  

Event Description

I received a new prodigy voice diabetes meter and up on inspection.I noted a usb port on the device which was an unexpected bonus for me i went to prodigymeter.Com website and downloaded the software noting that it was only available for microsoft vista and windows 7.I decided to download the software and see if it works.Well i didn't install properly on my microsoft windows 10 computer.The prodigy voice glucose meter uses add'l software to manage the data.This is also a microsoft diabetes management software product "microsoft sql server 2005 express edition", microsoft's mainstream supported ended on (b)(6) 2011 for the afore mentioned database management system.Furthermore, upon add'l research the sql 2005 server database is not officially support for windows 1.I am curious why would a glucose meter with data download capability would be submitted to the fda device approval process with unsupported software, just conjecture on my part.Lastly the requirement of windows 7 is also untenable as microsoft mainstream support for windows 7 sp1 ended on (b)(6) 2015 although free security updates will continue to 2020.So i called prodigy diabetes care tech support, the answer i received was install windows 7.

• Brand Name: PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): PRODIGY DIABETES CARE LLC
• MDR Report Key: 6692526
• MDR Text Key: 79580490
• Report Number: MW5070823
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PRODIGY VOICE
• Device Lot Number: V3-AUG16
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 120