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

Model Number ART27543-500 REV. A 04/19

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hyperglycemia (1905); Anxiety (2328)

Event Date 05/14/2022

Event Type  Injury  

Event Description

I applied abbott's freestyle libre sensor on my left arm.The sensor initially worked fine but soon it started to give an error that glucose unavailable try after 10 minutes.I checked after 10 minutes it gave the same error.That 10 minutes error message continued for many hours.I started to get anxious and felt chest tightness.Soon i was having difficulty breathing and almost crashed my car.Losing faith in the sensor and libre reader, i checked my bg with finger prick and it was above 500.I had to correct using a fiasp bolus.Next thing, the reader now showed a message to replace sensor.A 14 day sensor worked only few hours.Fda safety report id #:(b)(4).

• Brand Name: FREESTYLE LIBRE SENSOR AND READER
• Type of Device: SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 14430057
• MDR Text Key: 292043402
• Report Number: MW5109764
• Device Sequence Number: 1
• Product Code: PZE
• 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: 05/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ART27543-500 REV. A 04/19
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: SUPRADYN CALCIUM 65000 K
• Patient Outcome(s): Life Threatening
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian