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

Model Number 71940-01

Device Problem High Readings (2459)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Sweating (2444); Pallor (2468)

Event Date 10/25/2019

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 high readings issue was reported with use of the adc freestyle libre sensor.Customer received a sensor scan result of 187 mg/dl and self-treated with omalog (dose unknown).Customer subsequently experienced symptoms described as "tired, sweaty and pale".Paramedics was called who obtained a reading of 62 mg/dl on the hcp meter and treated the customer with glucagon injection.No further treatment was required.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

(device mfg date) has been updated based on the returned product download.Sensor (b)(4) has been returned and investigated.Visual inspection has been performed and no issues were observed.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).Sensor plug was properly seated in the mount.Removed the sensor plug and inspected the plug assembly, no issues were observed.Sensor was reprogrammed and current was applied to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.

Event Description

A high readings issue was reported with use of the adc freestyle libre sensor.Customer received a sensor scan result of 187 mg/dl and self-treated with omalog (dose unknown).Customer subsequently experienced symptoms described as "tired, sweaty and pale".Paramedics was called who obtained a reading of 62 mg/dl on the hcp meter and treated the customer with glucagon injection.No further treatment was required.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
• MDR Report Key: 9280724
• MDR Text Key: 165233950
• Report Number: 2954323-2019-08630
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599001018
• UDI-Public: 00357599001018
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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: 11/06/2019
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR