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

Model Number 71953-01

Device Problem Erratic or Intermittent Display (1182)

Patient Problems Hypoglycemia (1912); Vomiting (2144); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 10/10/2022

Event Type  Injury  

Event Description

The customer reported being unable to test due to an adc device display issue.The customer further reported experiencing symptoms described as "black out, sweaty, throwing up, feeling cold," a loss of consciousness and was unable to self-treat.The customer had contact with a healthcare professional at the hospital who provided sugar intravenously, fluids and was put under observation as treatment for the diagnosis of hypoglycemia.In addition, hcp obtained a blood glucose result of 60 mg/dl and 70 mg/dl when customer was discharged.No further information was provided.There was no report of death or permanent impairment associated with this event.

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.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.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.

• 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: 15764561
• MDR Text Key: 303389549
• Report Number: 2954323-2022-41145
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Device Catalogue Number: 71953
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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: Female