MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Fall (1848); Hypoglycemia (1912); Dizziness (2194)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a "start new sensor" and "sensor not found" message upon scanning the freestyle libre 2 sensor.As a result, customer was unable to obtain readings to monitor glucose.The customer became dizzy and fell over, subsequently hitting their knees and skull.A glucose result of 43 mg/dl was obtained on an unspecified meter and customer had contact with a healthcare professional.The customer was diagnosed with hypoglycemia and received iv glucose and unspecified oral medication for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.An extended investigation has been performed for the reported complaint.And it has been determined, that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed, and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, a physical investigation will be performed.And a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported, a "start new sensor".And "sensor not found" message, upon scanning the freestyle libre 2 sensor.As a result, customer was unable to obtain readings to monitor glucose.The customer became dizzy and fell over.Subsequently, hitting their knees and skull.A glucose result of 43 mg/dl was obtained on an unspecified meter.And customer had contact with a healthcare professional.The customer was diagnosed with hypoglycemia.And received iv glucose and unspecified oral medication for treatment.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 12837309
• MDR Text Key: 280972775
• Report Number: 2954323-2021-93067
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 71 KG