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

Model Number 71940-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Vomiting (2144); Diabetic Ketoacidosis (2364); Polydipsia (2604)

Event Date 05/20/2022

Event Type  Injury  

Event Description

A caller reported a "replace sensor" message with the adc device, and was therefore unable to obtain sensor readings.The customer developed symptoms of thirst and vomiting, and was taken to hospital where diagnosis of diabetic ketoacidosis was made.The customer was hospitalized for 2 days and treated with insulin (dose/type/frequency unknown).There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor 0m000mjkakw has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.Sensor found to be in state 5 (indicating normal termination).A cracked sensor neck was observed on the sensor plug assembly upon visual inspection.The sensor was reprogrammed to perform sim vivo testing (simulation of the electrical signal produced by the sensor tail) while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.Issue is not confirmed.An extended investigation has also 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 sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.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: 14734446
• MDR Text Key: 294279934
• Report Number: 2954323-2022-19906
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 54 KG