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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES 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 Pain (1994); Skin Irritation (2076); Infection, Pyrogenic (2246)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered is the case awareness date.The device mfg date is unknown.The date entered is the case awareness date.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported experiencing an infection during her 3 day wear of the adc freestyle libre sensor.Customer further reported experiencing "red and burned skin", pus, pain, and "tickle" at the sensor site.Customer had contact with a healthcare professional and was provided "physiological serum", tulle gras medical dressing, and fusidic acid ointment (antibiotic steroid) for treatment of the sensor site.The customer was also reportedly diagnosed with low blood sugar, but clarification has not been obtained at this time.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 and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrated 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.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
 
Event Description
Customer reported experiencing an infection during her 3 day wear of the adc freestyle libre sensor.Customer further reported experiencing "red and burned skin", pus, pain, and "tickle" at the sensor site.Customer had contact with a healthcare professional and was provided "physiological serum", tulle gras medical dressing, and fusidic acid ointment (antibiotic steroid) for treatment of the sensor site.The customer was also reportedly diagnosed with low blood sugar, but clarification has not been obtained at this time.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 INC.
1360 south loop road
alameda CA 94502 7001
Manufacturer Contact
devin dirstine
1360 south loop road
alameda, CA 94502-7001
5108644391
MDR Report Key7153291
MDR Text Key96002945
Report Number2954323-2017-09171
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 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
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 Received12/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2017
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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