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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE SENSOR 14 DAY; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE SENSOR 14 DAY; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71939-01
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 06/10/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product was returned to adc and this issue was not confirmed upon product return investigation.No product deficiency or malfunction 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.
 
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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 Key11527770
Report Number2954323-2021-51308
Device Sequence Number3971599
Product Code PZE
UDI-Device Identifier00357599001025
UDI-Public00357599001025
Combination Product (Y/N)N
PMA/510(K) Number
P160030
Number of Events Summarized1
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) 03/19/2021
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 Number71939-01
Device Catalogue Number71939
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/10/2020
Initial Report FDA Received Date03/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Patient Age73 YR
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