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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71702-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Cellulitis (1768); Discomfort (2330)
Event Date 11/28/2017
Event Type  Injury  
Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The date when the medical event occurred is unknown.The date listed is the date when abbott diabetes care became aware of the event.The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer¿s father, who is also a physician, reported customer experienced an infection while wearing an adc freestyle libre sensor.It was further reported the skin irritation has happened twice.The first time the skin was ¿irritated with redness¿, but this resolved without intervention.The second time the irritation appeared there was ¿redness and it was painful¿.Caller noted customer had contact with his healthcare provider, was diagnosed with cellulitis and prescribed unspecified antibiotics.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint there was no indication that the product did not meet specification.Dhrs (device history review) for all fs libre sensors and fs libre sensor kits within expiration at the time of complaint has been reviewed and the dhr review showed there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed and no tripped trends were observed.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
Customer¿s father, who is also a physician, reported customer experienced an infection while wearing an adc freestyle libre sensor.It was further reported the skin irritation has happened twice.The first time the skin was ¿irritated with redness¿, but this resolved without intervention.The second time the irritation appeared there was ¿redness and it was painful¿.Caller noted customer had contact with his healthcare provider, was diagnosed with cellulitis and prescribed unspecified antibiotics.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE LIBRE
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key7144673
MDR Text Key95721266
Report Number2954323-2017-09056
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
PMA/PMN Number
P160030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71702-01
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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