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

Model Number 71702-01

Device Problem Low Readings (2460)

Patient Problems Fever (1858); Hyperglycemia (1905); Unspecified Infection (1930); Paralysis (1997); Chills (2191); Loss of consciousness (2418)

Event Date 11/29/2018

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 receiving an unspecified low reading while wearing the adc freestyle libre sensor.On the morning of (b)(6) 2018, he experienced symptoms of chills, fever, inability to move his leg, and loss of consciousness.Customer was seen at the hospital where he was diagnosed with hyperglycemia and was treated with "massive infusions" of unspecified medication with antibiotic therapy.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported receiving an unspecified low reading while wearing the adc freestyle libre sensor.On the morning of (b)(6) 2018 he experienced symptoms of chills, fever, inability to move his leg, and loss of consciousness.Customer was seen at the hospital where he was diagnosed with hyperglycemia and was treated with "massive infusions" of unspecified medication with antibiotic therapy.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.  the reported complaint does not pertain to the freestyle libre reader.Therefore no further investigation into the reader is required.  dhrs (device history review) 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.    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.

• 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: 8303333
• MDR Text Key: 134967543
• Report Number: 2954323-2019-01017
• 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: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• 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?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91