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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 Abscess (1690); Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Fluid Discharge (2686)
Event Date 10/05/2018
Event Type  Injury  
Manufacturer Narrative
The reported product is not expected to be returned.Extended investigation is pending.A follow-up report will be filed if product is returned or additional information is obtained.The date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer reported experiencing an adverse skin reaction after 5 days of wearing an adc freestyle libre sensor, and reported experiencing symptoms described as itching, skin irritation, redness, and "wet" at the sensor site.The sensor detached and customer had contact with a doctor who "had to cut the spot and provide the wound support".Customer was additionally prescribed an unspecified ointment for treatment.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 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 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.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 adverse skin reaction after 5 days of wearing an adc freestyle libre sensor, and reported experiencing symptoms described as itching, skin irritation, redness, and "wet" at the sensor site.The sensor detached and customer had contact with a doctor who "had to cut the spot and provide the wound support".Customer was additionally prescribed an unspecified ointment for treatment.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 Key8034319
MDR Text Key125995801
Report Number2954323-2018-08326
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 06/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
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 Received06/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2018
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;
Patient Age25 YR
Patient Weight52
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