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

Model Number 71940-01

Device Problems Unable to Obtain Readings (1516); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Loss of consciousness (2418)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet 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 kits were reviewed and the dhrs showed the 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 the adc freestyle libre sensor detached on day 1 of wear after bumping into something.On (b)(6) 2021, as a result, the customer " felt light-headed and fell to on the floor," losing consciousness.The customer was able to "stand up and sit for a moment" and provide unspecified self-treatment.There was no third-party medical treatment provided.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) was returned and investigated.No physical damage was observed on the sensor patch, no issues were observed with the returned adhesive.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported the adc freestyle libre sensor detached on day 1 of wear after bumping into something.On (b)(6) 2021, as a result, the customer " felt light-headed and fell to on the floor," losing consciousness.The customer was able to "stand up and sit for a moment" and provide unspecified self-treatment.There was no third-party medical treatment provided.No further information was provided.There was no report of death or permanent injury 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: 11882339
• MDR Text Key: 252616643
• Report Number: 2954323-2021-70269
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 110