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

Model Number	71702-01
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Hyperglycemia (1905); Weakness (2145); Dizziness (2194)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer's product is not expected to be returned.A follow-up report will be filed once the product investigation is completed.The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care received a medwatch (mw5080850) report which reported the following information, in conjunction with a follow-up call to the customer: a customer reported receiving lower readings from her adc freestyle libre sensor than readings received on a competitor¿s meter.She further reported that on (b)(6) 2018 she experienced ¿dizziness and weakness¿ and had contact with a healthcare provider.Customer was diagnosed with hyperglycemia and treated with an unspecified ¿injection¿.While at the hcp visit customer was informed that her fasting glucose lab result was ¿very high¿ which surprised her because her readings using the libre sensor had been consistently low.She then performed comparison tests with the libre sensor and a competitor¿s meter (no readings provided) and determined the sensor was providing readings that were ¿lower by 30-50 points¿.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
Additional information: device mfg date has been updated based on the returned product download.Sensor (b)(4) has been returned and investigated.Visual inspection has been performed and no issues were observed.Extracted data from returned sensor using approved software.Sensor found to be in state 5 (indicating normal termination).The sensor plug was properly seated in the mount.Removed the sensor plug and inspected the plug assembly, no failure mode observed.Sensor was reprogrammed and current was applied to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.
Event or Problem Description
Abbott diabetes care received a medwatch (mw5080850) report which reported the following information, in conjunction with a follow-up call to the customer: a customer reported receiving lower readings from her adc freestyle libre sensor than readings received on a competitor¿s meter.She further reported that on (b)(6) 2018 she experienced ¿dizziness and weakness¿ and had contact with a healthcare provider.Customer was diagnosed with hyperglycemia and treated with an unspecified ¿injection¿.While at the hcp visit customer was informed that her fasting glucose lab result was ¿very high¿ which surprised her because her readings using the libre sensor had been consistently low.She then performed comparison tests with the libre sensor and a competitor¿s meter (no readings provided) and determined the sensor was providing readings that were ¿lower by 30-50 points¿.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 8170024
• Report Number: 2954323-2018-09659
• Device Sequence Number: 11114244
• Product Code: PZE
• UDI-Device Identifier: 00357599000851
• UDI-Public: 00357599000851
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 64