MAUDE Adverse Event Report: ABBOTT FREESTYLE GLUCOMETER AND STRIPS; GLUCOSE, DEHYDROGENASE, SYSTEM

Model Number DCGX074-N2607

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 01/16/2018

Event Type  malfunction  

Event Description

(b)(6) 2018, prescription (b)(4) obtained freestyle lite glucometer (product from lancets product of usa (b)(4) rev a 08/10 from (b)(4), (b)(4); (used sample strips initially followed by refilled strips, began monitoring 3 x daily through to (b)(6) 2018.Informed (b)(4) and abbott ((b)(4)).Abbott promised to send new meter with strips, did not receive over 1 wk; inform (b)(4) of egregious error - not removed from shelves.I have documented all readings/lot number.(b)(4) on (b)(4) 2018 - said "exp dates are ok" and have not received call from either abbott pharm rep or (b)(4) dept (refuses to f/u and take off shelf).I was told by abbott that the strips are "old." the following are the lot #s 1030956, exp 08/31/2019, (b)(4); i can give you the (01) numbers for the following: 1026467; 1030958; 1030956, exp 09/30/2019; 1026467, exp 08/31/2019 (i have the containers except one that i threw away.I have documented all readings through (b)(6) 2012.Here are a few examples of the erroneous readings: every am fasting 111 until (b)(6); on (b)(6) lot 1030956 am reading = pm reading of 128; left message to abbott cust.Care (after being told there was no record of my phone conversation; told i would be contacted the next day - no phone call.In short (b)(4) and abbott are not cooperating.Saw my md on (b)(6) 2018 - inforced that i need to resolve this issue.At this point i do not know what to do.I am reaching out to the fda for 2 reasons (other consumers have received glucose monitor strips from (b)(4) locally and probably beyond that are not correct, and i need to continue to monitor my own readings.Please call me (b)(6) and advise asap.This is affecting my health cardiovascular, headaches, etc.I can send copies of my readings, but trust me they are simply not accurate.I have cleared the equipment as per instructions, followed all directions appropriately.

• Brand Name: FREESTYLE GLUCOMETER AND STRIPS
• Type of Device: GLUCOSE, DEHYDROGENASE, SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 7259304
• MDR Text Key: 99994985
• Report Number: MW5075137
• Device Sequence Number: 1
• Product Code: LFR
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2010
• Device Model Number: DCGX074-N2607
• Device Catalogue Number: 70805
• Device Lot Number: SEE ABOVE FOR STRIPS
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other