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 Hypoglycemia (1912); Dizziness (2194)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

The product has been requested for 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 with the abbott diabetes care (adc) device was reported.A customer received unspecified higher sensor scan results compared to 55mg/dl readings obtained on a competitor brand meter.The customer experienced dizziness and was unable to self-treat, required coca-cola by a non-healthcare provider for treatment.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.Section d4 (serial number) and h4 (device mfg date) were updated based on returned product download.Section d4 (serial number) was updated from (b)(6).

Event Description

A high readings issue with the abbott diabetes care (adc) device was reported.A customer received unspecified higher sensor scan results compared to 55mg/dl readings obtained on a competitor brand meter.The customer experienced dizziness and was unable to self-treat, required coca-cola by a non-healthcare provider for treatment.No further treatment was reported.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 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 19067041
• MDR Text Key: 339666513
• Report Number: 2954323-2024-11871
• 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,Followup
• Report Date: 04/30/2024

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 Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2024
• 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