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

Model Number	71938-01
Medical Device Problem Codes	Failure to Power Up (1476); Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event 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
A complaint was received regarding no power by button or by the test strip using the adc device.As a result, the customer had a loss of consciousnesses and was provided insulin and juice by emergency services, and breakfast by the family member, for the diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE READER
• 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: 15129043
• Report Number: 2954323-2022-26466
• Device Sequence Number: 6603203
• Product Code: PZE
• UDI-Device Identifier: 00357599000981
• UDI-Public: 00357599000981
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/29/2022

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 Model Number: 71938-01
• Device Catalogue Number: 71936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 77 YR
• Patient Sex: Male