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

Model Number 71702-01

Device Problem High Readings (2459)

Patient Problems Fainting (1847); Hypoglycemia (1912)

Event Date 12/30/2018

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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a high readings issue with the adc freestyle libre, receiving a sensor scan reading of 188 mg/dl which was higher than he felt.The customer further reported that he fainted and his wife administered (b)(6) as treatment.No further treatment or intervention was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(4) has been returned and investigated.Visual inspection performed on the returned sensor patch, no issues observed.Data extracted using approved software and sensor found to be in state 5 (normal termination).Sensor plug was properly seated in mount.Visual inspection on sensor plug assembly performed, no failure mode was observed.Sensor placed into the simvivo test fixture in keithley mode, reprogrammed sensor and applied current to perform linearity test.Glucose count results were within specification.Issue is not confirmed.

Event Description

A customer reported a high readings issue with the adc freestyle libre, receiving a sensor scan reading of 188 mg/dl which was higher than he felt.The customer further reported that he fainted and his wife administered cola as treatment.No further treatment or intervention was reported.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8259400
• MDR Text Key: 133467487
• Report Number: 2954323-2019-00532
• 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
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 83