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

Lot Number 210815Q/SMOMOOOIDAJHR

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/30/2021

Event Type  malfunction  

Event Description

Pt attempted to apply new sensor and noticed that the needle on the sensor had come out of the package bent and that was preventing attachment to skin, pt is an experienced user with no prior issues.

• Brand Name: FREESTYLE LIBRE SENSOR KIT - 14 DAY
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 12787736
• MDR Text Key: 280809230
• Report Number: MW5105243
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 57599000101
• UDI-Public: 57599000101
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 210815Q/SMOMOOOIDAJHR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White