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

Model Number 71940-01

Device Problem Low Readings (2460)

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

Event Date 11/15/2020

Event Type  Injury  

Manufacturer Narrative

The libre sensor kit expiration date is 31-oct-2020.The medical event associated with this complaint case occurred on (b)(6) 2020 which confirms the usage of the device beyond the useful life of the device.Additional investigation activities are not required as the device met specifications when it was released and throughout its lifespan.No additional investigations are required as the sensor was expired at the time of use, and the device met its specification lifespan.A follow-up report will be submitted if any additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event the date of event 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 lower values when scanning the adc freestyle libre sensor compared to a competitor's brand meter.The caregiver stated the customer fell and lost consciousness.No further information was reported as the caregiver refused to troubleshoot further.The unspecified low-value scan may be consistent with hypoglycemia.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
• Manufacturer Contact: erica frank ; 1360 south loop road; alameda, CA 94502-7001 ; 5104242454
• MDR Report Key: 10877527
• MDR Text Key: 217458832
• Report Number: 2954323-2020-11504
• 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: 11/20/2020

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: 10/31/2020
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2020
• Initial Date FDA Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2020
• 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