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

Model Number 71992-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Muscle Weakness (1967)

Event Date 01/10/2023

Event Type  Injury  

Event Description

A caller reported a lower reading with the adc device, as compared to laboratory result.The caller reported the customer had symptoms of extreme weakness and low blood pressure, and was referred to hospital.At hospital, a sensor reading of 150 mg/dl was obtained as compared to a reported healthcare meter reading of "hi" (unknown the specific glucose result) and 1000 mg/dl from a laboratory blood glucose result.The results when plotted on a parkes error grid fall into the "out of range" zone, showing the difference in values to be clinically significant.The customer was treated with insulin (dose/type unknown) and hospitalized.The caller additionally mentioned concern of customer experiencing a "potential cardiac event", with no confirmation of diagnosis.While hyperglycemia is associated with an increased risk of cardiac issues, this increased risk occurs over a prolonged period of uncontrolled diabetes.There is no indication that lower readings from a single sensor would have caused or contributed to a potential cardiac event.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported product is not expected to be returned as the device was reportedly discarded.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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and freestyle libre sensors; no trends were identified that would indicate any product related issues.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.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: 16244633
• MDR Text Key: 308143989
• Report Number: 2954323-2023-04159
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization