MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 14 DAYS; SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED

Lot Number 200914Q

Device Problems Separation Failure (2547); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Event Description

Abbott freestyle libre 14 day sensor applicator/ sensor pack was defective.I purchased 6 kit and 1kit = 1 product and did not have any issue with first two kit but another two-kit had issue.In one of the kit, sensor applicator unable to release the sensor pack and it stuck.In another kit, i found two sensor pack1 attached with each other and that's why it was unable to patch in my arm.I talked to abbott customer care and they are providing new sensor but when i talked to them to report to fda, they just disconnected the call with "thank you for you call".Fda safety report id # (b)(4).

• Brand Name: FREESTYLE LIBRE 14 DAYS
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 11201329
• MDR Text Key: 227999133
• Report Number: MW5098883
• Device Sequence Number: 2
• Product Code: PZE
• Combination Product (y/n): Y
• 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: 01/14/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 200914Q
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 64