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

Model Number 71953-01

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A port issue was reported with the freestyle libre 2 reader.Customer reported that the reader would only power on with button press, however, not upon strip insertion.As a result, customer was unable to obtain readings and experienced symptoms of sweating and impaired vision.Customer was unable to self-treat and required treatment of oral glucose by third-party.It was further reported that customer had contact with a healthcare provider, however, no further details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre reader was reviewed and the dhrs showed the libre 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.

Event Description

A port issue was reported with the freestyle libre 2 reader.Customer reported that the reader would only power on with button press, however, not upon strip insertion.As a result, customer was unable to obtain readings and experienced symptoms of sweating and impaired vision.Customer was unable to self-treat and required treatment of oral glucose by third-party.It was further reported that customer had contact with a healthcare provider, however, no further details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported reader (b)(6) has been returned and investigated with retained test strips.Visual inspection was performed on the reader and no issues were observed.The reader powered on with with button but not with test strips.Reader was de-cased and debris inside the strip port was observed.Therefore, the issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A port issue was reported with the freestyle libre 2 reader.Customer reported that the reader would only power on with button press, however, not upon strip insertion.As a result, customer was unable to obtain readings and experienced symptoms of sweating and impaired vision.Customer was unable to self-treat and required treatment of oral glucose by third-party.It was further reported that customer had contact with a healthcare provider, however, no further details were provided.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: 12282766
• MDR Text Key: 265228556
• Report Number: 2954323-2021-79029
• 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,Followup
• Report Date: 12/14/2021

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
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 08/09/2021; 12/08/2021
• Supplement Dates FDA Received: 08/18/2021; 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2019
• 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