MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71938-01

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problems Fatigue (1849); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 07/13/2023

Event Type  Injury  

Event Description

Customer did not receive a replacement adc device.The replacement device was due to a battery/no power issue was reported with the adc blood glucose meter.Customer reported the meter would not power on with button press or test strip insertion.As a result, the customer experienced excessive sweating, confusion and tiredness.The customer stated they received medical treatment from someone other than themselves.No further information was provided.There was no report of death, serious injury or mistreatment associated with this event.

Manufacturer Narrative

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

Event Description

Customer did not receive a replacement adc device.The replacement device was due to a battery/no power issue was reported with the adc blood glucose meter.Customer reported the meter would not power on with button press or test strip insertion.As a result, the customer experienced excessive sweating, confusion and tiredness.The customer stated they received medical treatment from someone other than themselves.No further information was provided.There was no report of death, serious injury or mistreatment associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has 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 review) 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.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 17402392
• MDR Text Key: 319830420
• Report Number: 2954323-2023-32339
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P160030
• 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
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71938-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• 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