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

Model Number 71702-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fainting (1847); Hyperglycemia (1905); Dizziness (2194)

Event Date 11/28/2018

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.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

Customer reported her adc freestyle libre sensor detached after 1 day of wear.Customer further reported that on (b)(6) 2018, she experienced symptoms described as "could not talk", dizzy, and "passed out".Customer was seen at a hospital where a reading of "more than 500 mg/dl" was obtained on the hospital device and she was diagnosed with hyperglycemia and "given humalog insulin several times while hospitalized".It is unknown when the customer was released from the hospital.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.A dhr (device history review) for the fs libre sensor kit was reviewed and the dhr showed the libre sensor kit passed all tests prior to release.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

Customer reported her adc freestyle libre sensor detached after 1 day of wear.Customer further reported that on (b)(6) 2018, she experienced symptoms described as "could not talk", dizzy, and "passed out".Customer was seen at a hospital where a reading of "more than 500 mg/dl" was obtained on the hospital device and she was diagnosed with hyperglycemia and "given humalog insulin several times while hospitalized".It is unknown when the customer was released from the hospital.There was no report of death or permanent injury 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
• MDR Report Key: 8192080
• MDR Text Key: 131298204
• Report Number: 2954323-2018-09828
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599000196
• UDI-Public: 00357599000196
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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?: No
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention