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 Headache (1880); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Weakness (2145); Hot Flashes/Flushes (2153); Malaise (2359); Loss of consciousness (2418)

Event Date 08/06/2018

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

A customer reported receiving low readings on her adc freestyle libre sensor scan.On (b)(6) 2018, customer received an unspecified low reading on the sensor and experienced symptoms of malaise, nausea, headache, weakness, vomiting, hot flashes, and loss of consciousness.Customer presented to the hospital, where a reading of 600 mg/dl was obtained on a hospital meter and the customer was diagnosed with hyperglycemia.The customer was treated with oral morphine sulfate and novorapid insulin.The customer further noted that the freestyle libre had been continually providing lower readings than the hospital meter when comparing the data, and that her "eyes have become much worse" as a result of the lower readings over the 14 day course of libre sensor wear due to "sugar damage".There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: (serial number) and (device mfg date) have been updated based on the returned product.Visual inspection has been performed on the returned sensor patch and no issues were observed.The sensor plug was properly seated in mount.Performed visual inspection on sensor plug assembly, no failure mode was observed.Extracted data from returned sensor using approved software.Sensor found to be in state 5.Sensor inserted into the sim-vivo test fixture.Sensor was reprogrammed and applied current to perform linearity testing.All results were within specification.No product deficiency was identified.The complaint was not confirmed.

Event Description

A customer reported receiving low readings on her adc freestyle libre sensor scan.On (b)(6) 2018, customer received an unspecified low reading on the sensor and experienced symptoms of malaise, nausea, headache, weakness, vomiting, hot flashes, and loss of consciousness.Customer presented to the hospital, where a reading of 600 mg/dl was obtained on a hospital meter and the customer was diagnosed with hyperglycemia.The customer was treated with oral morphine sulfate and novorapid insulin.The customer further noted that the freestyle libre had been continually providing lower readings than the hospital meter when comparing the data, and that her "eyes have become much worse" as a result of the lower readings over the 14 day course of libre sensor wear due to "sugar damage".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
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8026603
• MDR Text Key: 125744400
• Report Number: 2954323-2018-08235
• 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

• 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: 11/05/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2018
• 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: 30 YR
• Patient Weight: 57