MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 07/24/2022

Event Type  Injury  

Event Description

Freestyle libre 2 is seriously unreliable or defective; 5 out 7 sensors / cgm's defective from box / new or continuously stream unreliable or incorrect blood sugar information.Google: national failure rate very high for a medical device.Item should be pulled from market and be prohibited from public sale or distribution.Fda safety report id# (b)(4).

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 15113278
• MDR Text Key: 296786116
• Report Number: MW5111140
• Device Sequence Number: 5
• Product Code: QLG
• 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: 07/24/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ATORVASTATIN ; CLOPIDOGREL; COREG; CRANBERRY; D3; FISH OIL ; INSULIN ; LISINOPRIL ; METFORMIN ; NITRO-STAT; VITAMIN B12
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic