MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE SENSOR KIT; SENSOR, GLUCOSE, INVASIVE

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

On three occasions the abbot labs freestyle libre sensor kit malfunctioned.First time in (b)(6) 2022 failed to connect with provided meter; 2nd time in (b)(6) of 2022> apparatus fell off after 10 days (14 day product); 3rd time in (b)(6) of 2022> defective applicator> needle bent flat on opening.Tried to call abbot 5 times> 3 calls answered in (b)(6) with poor english speakers; 2 call answered in (b)(6) and was disconnected.Left contact information on all calls.No follow up by abbott.As stated above, unable to contact any customer service or receive return phone calls.These kits cost in the (b)(6) range each, requires 2+ every month.Started using this item to monitor sugar level due to side effect from covid 19 shots (3) which results in a change to stable diabetes.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE SENSOR KIT
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 14946403
• MDR Text Key: 295501473
• Report Number: MW5110717
• Device Sequence Number: 1
• Product Code: MDS
• 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: 07/02/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White