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

Model Number SENSOR 71702-01/READER 71525-01

Device Problem High Readings (2459)

Patient Problem Hypoglycemia (1912)

Event Date 11/23/2017

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.Note: 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 in addition to a port issue with the reader.Customer reported receiving a sensor scan result of "over 300 mg/dl" and stated the trend arrow was pointing diagonal-upwards.In addition, the customer reported that the reader did not function when the test strips were inserted.No symptoms were reported but customer had contact with healthcare provider and a reading of 53 mg/dl was obtained on the hcp meter.Customer was treated with glucose.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

No product has been returned and a valid reader serial number has not been provided.Extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The reported readings complaint does not pertain to the freestyle libre reader.Therefore no further investigation into the reader will be required for the readings issues.The reported port complaint does not pertain to the precision test strips.No strip related investigation activities are will be performed for the port complaint.As a serial number was not provided for the libre reader, the manufacturer of freestyle libre readers, was contacted to conduct an internal investigation.They determined that their process continues to remain in control per adc requirements and there was no deviations or abnormalities which could have caused the complaint.A tripped trend review was completed for the port related issue and freestyle libre readers.No trips were observed.Dhrs (device history review) for the freestyle libre sensor and libre sensor kit were reviewed and the dhrs showed the 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.

Event Description

A high readings issue was reported with use of the adc freestyle libre sensor in addition to a port issue with the reader.Customer reported receiving a sensor scan result of "over 300 mg/dl" and stated the trend arrow was pointing diagonal-upwards.In addition, the customer reported that the reader did not function when the test strips were inserted.No symptoms were reported but customer had contact with healthcare provider and a reading of 53 mg/dl was obtained on the hcp meter.Customer was treated with glucose.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: 7136617
• MDR Text Key: 95445778
• Report Number: 2954323-2017-08980
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SENSOR 71702-01/READER 71525-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2017
• Is the Device Single Use?: No
• 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 Weight: 101