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

Model Number 71940-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Lethargy (2560); Polydipsia (2604)

Event Date 03/01/2021

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 manufacturing 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 customer reported a difference in readings when scanning freestyle libre sensor with reader and librelink application.However, the customer did not provide the difference in readings, which he indicated led to experiencing fatigue and thirst, and loss of consciousness.The customer required treatment of sugar, banana, and sugary drink from a healthcare professional.The customer provided laboratory blood glucose results of 110 mg/dl and 125 mg/dl, post-treatment.A difference in readings between scan with reader and scan with librelink of 76 mg/dl and 82 mg/dl, taken unspecified time after medical event, was also provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and a valid serial number has not been provided for reader and sensor.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and libre reader, no trends were identified that would indicate any product related issues.A tripped trend review was conducted for the reported complaint and fs libre sensor, no trends were identified that would indicate any product related issues.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.This serves as a correction report.Section d4 (serial no) and section h10 (addtl mfg narrative) was incorrectly documented in follow up report number 1.Correction has been made here.

Event Description

A customer reported a difference in readings when scanning freestyle libre sensor with reader and librelink application.However, the customer did not provide the difference in readings, which he indicated led to experiencing fatigue and thirst, and loss of consciousness.The customer required treatment of sugar, banana, and sugary drink from a healthcare professional.The customer provided laboratory blood glucose results of 110 mg/dl and 125 mg/dl, post-treatment.A difference in readings between scan with reader and scan with librelink of 76 mg/dl and 82 mg/dl, taken unspecified time after medical event, was also provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and a valid serial number has not been provided for the reader.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and the libre reader, no trends were identified that would indicate any product related issues.Dhrs (device history review) for the libre sensor and sensor kit were reviewed and the dhrs showed the 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 customer reported a difference in readings when scanning freestyle libre sensor with reader and librelink application.However, the customer did not provide the difference in readings, which he indicated led to experiencing fatigue and thirst, and loss of consciousness.The customer required treatment of sugar, banana, and sugary drink from a healthcare professional.The customer provided laboratory blood glucose results of 110 mg/dl and 125 mg/dl, post-treatment.A difference in readings between scan with reader and scan with librelink of 76 mg/dl and 82 mg/dl, taken unspecified time after medical event, was also provided.There was no report of death or permanent injury 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
• MDR Report Key: 11558331
• MDR Text Key: 241928291
• Report Number: 2954323-2021-63463
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/15/2021; 06/17/2021
• Supplement Dates FDA Received: 04/21/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention