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

Model Number 71940-01

Device Problem Low Readings (2460)

Patient Problems Hypoglycemia (1912); Hot Flashes/Flushes (2153); Loss of consciousness (2418); Diaphoresis (2452)

Event Date 07/28/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A low reading issue was reported with the adc device.Customer received low sensor scan results compared to readings obtained on another adc meter and experienced symptoms described as ¿feeling really hot,¿ sweating, and loss of consciousness.The customer was unable to self-treat and had contact with an hcp who provided a glucose injection as treatment.There was no report of death or permanent impairment associated with this event.A sensor scan result of 50 mg/dl was reported compared to an adc meter reading of 200 mg/dl.The results were plotted on a parkes error grid and fell ¿out of range¿, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported medical 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.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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.

Event Description

A low reading issue was reported with the adc device.Customer received low sensor scan results compared to readings obtained on another adc meter and experienced symptoms described as ¿feeling really hot,¿ sweating, and loss of consciousness.The customer was unable to self-treat and had contact with an hcp who provided a glucose injection as treatment.There was no report of death or permanent impairment associated with this event.A sensor scan result of 50 mg/dl was reported compared to an adc meter reading of 200 mg/dl.The results were plotted on a parkes error grid and fell ¿out of range¿, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported medical 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: 15331711
• MDR Text Key: 299035069
• Report Number: 2954323-2022-31897
• 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,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: 71940-01
• Device Catalogue Number: 71940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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
• Patient Sex: Male