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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71940-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Swelling (2091)
Event Date 01/23/2020
Event Type  Injury  
Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.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 products.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.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 experiencing a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as "pain, swelling and exudate" at the sensor site.Customer had contact with a healthcare professional and received clavulanic acid for treatment.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Additional information: (serial number) was updated from (b)(6) to (b)(6) in the final report.Sensor (b)(6) has been returned and investigated.Visual inspection on sensor patch has been performed and no issues were observed.The sensor adhesive was observed to be returned and intact during visual inspection.An extended investigation has also been performed on the returned product.Only the puck and plug have been returned; applicator and sharp were not returned.A no product returned investigation was previously conducted and indicates that the indicates that the missing applicator and sharp passed all tests prior to release.The device history record (dhr) has been reviewed and verified that the unit passed all tests on the line.Dose audit reports and environmental monitoring reports, including bioburden and endotoxin testing, were reviewed and demonstrated that all monitoring processes continue to meet requirements.No malfunction or product deficiency was identified, therefore, it is not confirmed.
 
Event Description
Customer reported experiencing a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as "pain, swelling and exudate" at the sensor site.Customer had contact with a healthcare professional and received clavulanic acid for treatment.There was no report of death or permanent impairment associated with this event.
 
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Brand Name
FREESTYLE LIBRE 14 DAY
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key9677385
MDR Text Key178011978
Report Number2954323-2020-01036
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 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71940-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2020
Initial Date Manufacturer Received 01/24/2020
Initial Date FDA Received02/06/2020
Supplement Dates Manufacturer Received06/05/2020
Supplement Dates FDA Received06/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient Weight122
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