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

Model Number 71940-01

Device Problem High Readings (2459)

Patient Problems Fatigue (1849); Headache (1880); Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 06/08/2023

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 record) for the libre sensor and sensor kit were reviewed, and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered in section b3 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 high readings issue with the adc device.The customer reported higher sensor readings, with symptoms of headache, drowsiness, hot flashes with sweating, difficult to breathe, and a loss of consciousness.The customer was taken to hospital where they were provided treatment to raise glucose levels.The customer reported additional treatment of steroids, antibiotics, and insulin (dose/type unknown).There was no report of death or permanent injury associated with this event.A readings comparison of 125 mg/dl with the sensor against 49 mg/dl and 69 mg/dl with a healthcare meter was provided.The results when plotted on a parkes error grid fall into the "d" zone, showing the difference in values to be clinically significant.

• 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: 17187833
• MDR Text Key: 317719802
• Report Number: 2954323-2023-26652
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female