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

Model Number	71940-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported receiving a low reading from their adc device.Customer reported a low reading of 40 mg/dl which was lower than lab reading of 200 mg/dl.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report.The sensor kit expiration date is march 31, 2019.The case awareness date is (b)(6) 2022, which confirms that the device is beyond the useful life.Additional investigation activities are not required as the device met specification when it was released and throughout its lifespan.The device manufacturer date for the reported sensor 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: 14084146
• Report Number: 2954323-2022-11910
• Device Sequence Number: 20218411
• Product Code: PZE
• UDI-Device Identifier: 00357599000196
• UDI-Public: 00357599000196
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2019
• 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: 03/22/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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
• Patient Sex: Unknown