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 Fall (1848); Hypoglycemia (1912); Weakness (2145); Loss of consciousness (2418)

Event Date 06/27/2020

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 customer reported incorrect glucose precision values while wearing the adc freestyle libre sensor.On (b)(6) 2020 the customer reported scanned value of 125 mg/dl, 140 mg/dl, and 146 mg/dl, however, they became pale and experienced weakness, a fall, a loss of consciousness.The customer was treated by his parents with (b)(6) for his symptoms.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Section h4 device mfg date updated based on returned product download.Sensor (b)(6) 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).No failure modes were observed on the sensor plug assembly upon visual inspection.Linearity test was performed, and the results were within specification.No malfunction or product deficiency was identified.

Event Description

A customer reported incorrect glucose precision values while wearing the adc freestyle libre sensor.On (b)(6) 2020 the customer reported scanned value of 125 mg/dl, 140 mg/dl, and 146 mg/dl, however, they became pale and experienced weakness, a fall, a loss of consciousness.The customer was treated by his parents with coca-cola for his symptoms.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported incorrect glucose precision values while wearing the adc freestyle libre sensor.On (b)(6) 2020 the customer reported scanned value of 125 mg/dl, 140 mg/dl, and 146 mg/dl, however, they became pale and experienced weakness, a fall, a loss of consciousness.The customer was treated by his parents with coca-cola for his symptoms.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specifications.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre 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.

• 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: 10246244
• MDR Text Key: 197979260
• Report Number: 2954323-2020-04610
• 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: 10/02/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/10/2020; 09/18/2020
• Supplement Dates FDA Received: 08/04/2020; 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Weight: 34