MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hyperglycemia (1905); Hot Flashes/Flushes (2153); Diaphoresis (2452); Polydipsia (2604)

Event Date 08/21/2022

Event Type  Injury  

Event Description

A complaint was received regarding the detachment of the adc device.As a result, the customer experienced symptoms of dehydration, feeling hot, sweaty, and increased thirst, and has a blood glucose test of 390 mg/dl obtained by the nurse.The nurse provided the customer with rapid insulin and a glass of water as treatment.Additional treatment of saline infusion was provided by the emergency services who then transported the customer to a hospital where a blood glucose test of 420 mg/dl was obtained on the healthcare provider's meter.The customer was treated with rapid and lantus insulin and no further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time, product has not yet been returned.The sensor kit expiration date is 31-may-2022.The medical event associated with this complaint occurred on (b)(6) 2022 which indicates usage of the device beyond the useful lifespan.No additional investigation is required as the sensor was expired at the time of use, and the device met its specification lifespan.The device manufacturing 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.

• Brand Name: FREESTYLE LIBRE 2
• 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: 15365904
• MDR Text Key: 299353594
• Report Number: 2954323-2022-32582
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K193371
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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; Hospitalization