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

Model Number 71992-01

Device Problem High Readings (2459)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Dizziness (2194)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg 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 high readings issue was reported with the abbott diabetes care (adc) device.A customer reported that after applying a new adc device on (b)(6) 2024, several high scans results were obtained and they are as followed; at 1:18 scan of 212mg/dl, at 4:35 scan of 172 mg/dl, and at 12:45 scan of 154 mg/dl was received which was compared to a 118 mg/dl obtained from an unspecified device.The customer reported self-treating with "snack".At 20:15, a scan of 269 mg/dl and at 22:35, a scan of 281 mg/dl were received on the adc device.Based on the scan results, the customer self-treated with insulin "5.0 points per units" (type unknown).The following day, the customer consequently experienced symptoms described as "feeling crashing and felt really bad".The customer spouse provided food for treatment however, the customer "felt bad" and the emergency services were called.The police arrived and a blood glucose result of 24 mg/dl was obtained on an unspecified device and the customer was provided "soda" for treatment.The customer was taken to the hospital were a blood glucose test of 81 mg/dl was obtained and was provided electrolytes for treatment.Post-treatment, it was further that sensor scan of 117 mg/dl was obtained compared to readings of 121 mg/dl and 313 mg/dl reported receiving from an unspecified device.The customer was able to self-treat with 23 units of insulin (type unknown).At 02:30 on (b)(6) 2024, sensor scan of 288 mg/dl was received, at 05:00, sensor scan of 230 was received, and at 07:05, sensor scan of 165 mg/dl was received.The customer able to self-treat with "half dose" of insulin.No further information was reported.The customer was capable of self-treating after receiving third party treatment.There was no report of death or permanent impairment associated with this event.

• 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: 19005920
• MDR Text Key: 338979873
• Report Number: 2954323-2024-10519
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: (01)00357599800000(17)2024-06-30(10)KTP007937(91)71992-01-0006
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2024
• 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 Age: 56 YR
• Patient Sex: Male