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

Model Number	71942-01
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	09/30/2021
Type of Reportable Event	Malfunction
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 is 31-jan-19.Case awareness date is 30-sep-21, which confirms device is beyond the useful life.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.
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.
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 is 31-jan-19.Case awareness date is 30-sep-21, which confirms device is beyond the useful life.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 as d1 - brand name,d2b - procode ,d4 - model no and g4 - pma/510(k) # was incorrectly documented in the initial report.Correction have been made.

• Brand Name: LIBRE SENSOR FREESTYLE
• 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: 12584976
• Report Number: 2954323-2021-87379
• Device Sequence Number: 4344575
• Product Code: PZE
• UDI-Device Identifier: 00357599000851
• UDI-Public: 00357599000851
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 10/15/2021

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 Model Number: 71942-01
• Device Catalogue Number: 71942
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1