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 Dyspnea (1816); Palpitations (2467)

Event Date 11/06/2019

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 low reading issue was reported with the use of the adc freestyle libre sensor.On (b)(6) 2019, customer received unspecified low reading and experienced palpitation and shortness of breath.Customer received unspecified treatment by the hcp.Additionally customer reported sensor scans of 95 mg/dl, 50 mg/dl and 96 mg/dl compared to readings of 160 mg/dl, 120 mg/dl and 182 mg/dl respectively obtained on the competitor meter on an unspecified date.No further information was provided and attempts to gather further information has thus far been unsuccessful.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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, the case will be re-opened and a physical investigation will be performed.Based on the additional information received, this case is deemed to be non reportable as the customer did not receive any self or third party treatment.

Event Description

A low reading issue was reported with the use of the adc freestyle libre sensor.On (b)(6) 2019, customer received unspecified low reading and experienced palpitation and shortness of breath.Customer received unspecified treatment by the hcp.Additionally customer reported sensor scans of 95 mg/dl, 50 mg/dl and 96 mg/dl compared to readings of 160 mg/dl, 120 mg/dl and 182 mg/dl respectively obtained on the competitor meter on an unspecified date.No further information was provided and attempts to gather further information has thus far been unsuccessful.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: 9377044
• MDR Text Key: 168037827
• Report Number: 2954323-2019-09273
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 65