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

Model Number	71940-01
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A caller reported that the customer obtained an "incompatible sensor" message upon scanning the adc device.The customer felt hypoglycemic and was transferred to the hospital where he received unspecified treatment.No additional information was provided.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
At this time, product has not yet been returned.The sensor kit expiration date is 28-feb-2019.The medical event associated with this complaint occurred on (b)(6) 2022 which indicates usage of the device beyond the useful lifespan.No additional investigation is required as the sensor was expired at the time of use, and the device met its specification lifespan.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The exact date of event is unknown.The date entered is per the customer's report of "last week" [from the awareness date of the event].The device manufacturing 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.

• 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13689366
• Report Number: 2954323-2022-07473
• Device Sequence Number: 16620944
• Product Code: PZE
• UDI-Device Identifier: 00357599000196
• UDI-Public: 00357599000196
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 03/07/2022

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: 02/28/2019
• 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: 02/21/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Male