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

Model Number	71702-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported sensor has been returned and investigated.Visual inspection has been performed on the returned sensor and no issues were observed with the sensor or with the adhesive pads.Blood was present on the adhesive and sensor plug's snaps were curled indicating that the sensor was inserted properly.A review of the dhrs (device history review) showed no rework or deviations at the time of manufacture.The complaint is not confirmed.
Event or Problem Description
A healthcare provider reported that on (b)(6) 2018 a customer¿s adc freestyle libre sensor detached while removing her clothes.Customer began to experience ¿sweating of hands, she became irritated and her stomach got itchy¿.Customer contacted her endocrinologist and was instructed to self-administer a glucagon injection.No additional treatment was required.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.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
A healthcare provider reported that on (b)(6) 2018 a customer¿s adc freestyle libre sensor detached while removing her clothes.Customer began to experience ¿sweating of hands, she became irritated and her stomach got itchy¿.Customer contacted her endocrinologist and was instructed to self-administer a glucagon injection.No additional treatment was required.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: 7815298
• Report Number: 2954323-2018-06376
• Device Sequence Number: 186203
• Product Code: PZE
• UDI-Device Identifier: 00357599000851
• UDI-Public: 00357599000851
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/28/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: 62 YR
• Patient Weight: 82