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 Fall (1848); Hyperglycemia (1905)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated the device was discarded.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor kit was reviewed and the dhrs showed the libre sensor kit passed all tests prior to release.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported the customer's adc freestyle libre sensor detached prematurely after 2 days of wear.As a result, the customer was unable to monitor his blood glucose and he fell which resulted in him bumping his head on the floor.The customer was unable to self-treat, requiring an unspecified injection and food as treatment by a non-healthcare professional.The customer was taken to the hospital where he was diagnosed with hyperglycemia but there was no report of any further treatment.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 12748976
• MDR Text Key: 280008007
• Report Number: 2954323-2021-91188
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160030
• 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
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 101