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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71562-01
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
Manufacturer Narrative
No product has been returned. Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification. Dhrs (device history review) for the fs libre reader were reviewed and the dhrs showed the fs libre reader passed all tests prior to release. Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release. If the product is returned, the case will be re-opened and a physical investigation will be performed. All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported receiving erratic readings on their adc freestyle libre sensor. Customer reported receiving readings of 70 mg/dl, 300 mg/dl, 100 mg/dl and 350 mg/dl within 10 minutes. 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.
 
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Brand NameFREESTYLE LIBRE PRO
Type of DeviceFLASH 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 Key11872467
MDR Text Key255343392
Report Number2954323-2021-70139
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P150021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model Number71562-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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