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

Model Number 72122-01

Device Problem No Device Output (1435)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 09/17/2023

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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A testing issue was reported with the abbott diabetes care (adc) reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, customer experienced "tremor", "pale", and was unable to self-treat, requiring third-party treatment of "two sugar sachets and bread" orally by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned.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.The device history review (dhrs) for the libre 2 reader were reviewed and the dhrs showed the libre 2 reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.On the previous initial submission (2954323-2023-46152) section(s) h2 - if follow-up, what type?, h3 - device evaluated by mfg?, h6 - adverse event problem: type of investigation/investigation findings/investigation conclusions.H10 - additional mfg narrative were incorrectly documented.

• Brand Name: LIBRE 2 READER FREESTYLE
• 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: 17947946
• MDR Text Key: 325793927
• Report Number: 2954323-2023-46152
• 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: 10/17/2023

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: 72122-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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