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

Model Number 71953-01

Device Problem Packaging Problem (3007)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418); Skin Infection (4544)

Event Date 12/22/2021

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

Event Description

A customer reported a medical event related to not receiving a replacement freestyle libre reader.The customer reported that his car was broken into and his reader was stolen.A replacement reader was ordered however upon receiving the replacement, the customer received the wrong order (a reader e-card).The customer was not able to monitor his glucose consequently, he experienced a loss of consciousness and was seen at a hospital.The customer was diagnosed with hyperglycemia and hospitalized.The customer further reported infection in his foot and a procedure was performed to remove infected tissue.The customer had a couple of check-ups and he was prescribed antibiotics.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: 13310706
• MDR Text Key: 284148389
• Report Number: 2954323-2022-02368
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• 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?: No
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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; Hospitalization
• Patient Sex: Male
• Patient Weight: 82 KG