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

Model Number 71953-01

Device Problem Premature Discharge of Battery (1057)

Patient Problems Headache (1880); Hyperglycemia (1905)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

The requested product has been returned and investigation is in process.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered in section h4 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 battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer experienced hyperglycemia and a headache and was unable to self-treat, requiring hcp administration of intravenous insulin for a diagnosis of diabetic ketoacidosis.The customer was reportedly admitted to the hospital for two days; however, no further treatment was indicated.There was no report of death or permanent impairment associated with this event.

Event Description

A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer experienced hyperglycemia and a headache and was unable to self-treat, requiring hcp administration of intravenous insulin for a diagnosis of diabetic ketoacidosis.The customer was reportedly admitted to the hospital for two days; however, no further treatment was indicated.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no damage or evidence of fire was observed.Performed load test on the usb charger and results were within specification range (4.75v-5.25v).Visual inspection has been performed on the power adapter and no issues were observed.The power adapter voltage was measured to be within specification range (4.75v-5.25v).The returned reader was further investigated and de-cased.Visual inspection has been performed on the de-cased reader and the stm processor was present.Reader powered on with button depression and the battery was sufficiently charged.Visually inspected the returned usb charger and usb cable and no damage was observed.Performed a continuity test on the returned usb cable using cable tester and no problem was found.Therefore, the issue is not confirmed.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: 18170329
• MDR Text Key: 328539247
• Report Number: 2954323-2023-50675
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• 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
• Patient Age: 53 YR
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White