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

Model Number	71702-01
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	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform linearity testing while in the test fixture.All results were within specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Sensor kit expiration date was determined to be 28-feb-2019.Aware date of this issue was 05-feb-2021, which confirms the usage beyond the useful life of the device.Additional investigation activities are not required at this time 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.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h3 (device evaluated by manufacturer?), h4 (device mfg date), h6 (adverse event problem) and h10 (addtl mfg narrative) were incorrectly documented in the initial report.Correction has been made.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FREESTYLE LIBRE SENSOR 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: 11316119
• Report Number: 2954323-2021-03868
• Device Sequence Number: 3692347
• Product Code: PZE
• UDI-Device Identifier: 00357599000202
• UDI-Public: 00357599000202
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 02/23/2021

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: 06/30/2021
• Device Model Number: 71702-01
• Device Catalogue Number: 71702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/12/2021; 02/15/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/12/2021; 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 70 YR