MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71940-01
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Codes	Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, product has not yet been returned.It has been determined that there was no indication that the product did not meet specification.Sensor kit expiration date is 30-jun-19.Medical event associated with this complaint case occurred on (b)(6) 2021 which confirms the usage of the device beyond the useful life of the device.Additional investigation activities are not required as the device met specification when it was released and throughout its lifespan.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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 or Problem Description
The wife of customer reported that the adc freestyle libre sensor "did not apply" and customer was unable to obtain scan readings.The customer experienced a loss of consciousness, an ambulance was called, and he was treated with fast acting insulin.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 12609035
• Report Number: 2954323-2021-88024
• Device Sequence Number: 1271209
• Product Code: PZE
• UDI-Device Identifier: 00357599000196
• UDI-Public: 00357599000196
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

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 Expiration Date: 06/30/2019
• Device Model Number: 71940-01
• Device Catalogue Number: 71536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/11/2021
• 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: 61 YR
• Patient Weight: 104