MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Sweating (2444); Pallor (2468)

Event Date 08/16/2020

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg 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 caregiver reported that the customer¿s adc freestyle libre sensor fell off after 2 days of wear.The customer experienced symptoms described as ¿dry and pale, sweat, and a loss of consciousness¿ and was provided oral glucose by her husband.It was further reported the customer was diagnosed with hypoglycemia but no additional treatment information was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

No product has been returned, and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint.And there was no indication, that the product did not meet specification.Clinical data was reviewed, and found no indication of any product performance issues that would be expected to result or contribute to customer complaints.A tripped trend review was completed for the reported complaint and libre sensor, and there were no adverse trends, that indicate any product related issues.If product is returned, the case will be re-opened and a physical investigation will be performed.Section d3 (email) and section g1 were updated to reflect current contact information.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caregiver reported, that the customer¿s adc freestyle libre sensor fell off after (b)(6) days of wear.The customer experienced symptoms described as ¿dry and pale, sweat, and a loss of consciousness¿.And was provided oral glucose by her husband.It was further reported, the customer was diagnosed with hypoglycemia, but no additional treatment information was reported.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 11023629
• MDR Text Key: 221895210
• Report Number: 2954323-2020-13640
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 49