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

Model Number 71938-01

Device Problems Display or Visual Feedback Problem (1184); Unable to Obtain Readings (1516)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Loss of consciousness (2418)

Event Date 05/12/2022

Event Type  Injury  

Event Description

The customer reported being unable to test due to a adc device display issue.The customer further reported experiencing symptoms described as throwing up and a loss of consciousness.The customer had contact with a healthcare professional at the hospital who provided dexilant (gastric acid secretion reducer) for treatment.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 freestyle libre reader was reviewed and the dhrs showed the freestyle 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.

Manufacturer Narrative

The reader (b)(6) was returned and visually inspected.No issues were observed.Performed built-in reader test.All tests passed.Display issue was not observed.Visual inspection has been performed on usb (universal serial bus) cable and no issues were observed.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

The customer reported being unable to test due to a adc device display issue.The customer further reported experiencing symptoms described as throwing up and a loss of consciousness.The customer had contact with a healthcare professional at the hospital who provided dexilant (gastric acid secretion reducer) for treatment.No further information was provided.There was no report of death or permanent impairment associated with this event.

• 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: 14889393
• MDR Text Key: 295151889
• Report Number: 2954323-2022-22173
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71938-01
• Device Catalogue Number: 71938-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other