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

Model Number 71953-01

Device Problem Device Alarm System (1012)

Patient Problems Fall (1848); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 12/04/2021

Event Type  Injury  

Manufacturer Narrative

At this time, product has not yet been returned and a valid serial number has not been provided.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.A tripped trend review was conducted for the reported complaint and libre reader; no trends were identified that would indicate any product-related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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.

Event Description

A customer reported was missing the glucose alarm while wearing the adc freestyle libre 2 reader.On (b)(6) 2021, as a result, the customer fell and had a loss of consciousness and was provided first aid and a glucagon injection by the mother for treatment.No further information was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: section d4 (serial no) and section h4 (device mfg date) have been updated based on returned product investigation.The reader mdgb186-g1651 has been returned and investigated.Visual inspection was performed on the returned reader and the reader casing was observed to be cracked.An extended investigation has also been performed on the reported complaint.Performed a visual inspection revealed a minor crack in the exterior casing.The investigation determined this would not have had an impact on the functionality of the reader, as the reader turned on with a button press.The reader was able to set time and date as well as validate uom (units of measurement).The isf (interstitial fluid) log was downloaded using approved software.The alarm data was analyzed for the time of the complaint 20:45 04dec21.All alarms were observed to be enabled.Signal loss and low glucose alarms were tested and functioned correctly.As a result, this issue is not confirmed.Dhr (device history record) was reviewed for the libre reader and the dhr showed the libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported was missing the glucose alarm while wearing the adc freestyle libre 2 reader.On (b)(6) 2021, as a result, the customer fell and had a loss of consciousness and was provided first aid and a glucagon injection by the mother for treatment.No further information was reported.There was no report of death or permanent injury 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: 13012748
• MDR Text Key: 282320651
• Report Number: 2954323-2021-95609
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/07/2022

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: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 110 KG