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

Model Number 71953-01

Device Problems No Display/Image (1183); Unable to Obtain Readings (1516)

Patient Problem Hypoglycemia (1912)

Event Date 06/20/2021

Event Type  Injury  

Manufacturer Narrative

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 dhrs (device history record) for the libre reader were 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 healthcare professional reported that the freestyle libre 2 reader display was missing pixels, and the reader could not be operated.As a result, the customer's blood glucose could not be monitored, and the customer had contact with the healthcare professional.The customer was determined to be hypoglycemic, and required treatment of glucose gel.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) was returned and investigated.Visual inspection was performed on the returned reader and no issue was observed.The built-in reader test was performed on the returned reader.All tests passed.There were no observations of unexpected characters/screen appearance.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A healthcare professional reported that the freestyle libre 2 reader display was missing pixels, and the reader could not be operated.As a result, the customer's blood glucose could not be monitored, and the customer had contact with the healthcare professional.The customer was determined to be hypoglycemic and required treatment of glucose gel.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
• MDR Report Key: 12102437
• MDR Text Key: 259573954
• Report Number: 2954323-2021-74507
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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: 07/20/2021
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR