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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 07/17/2019
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 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 infection while wearing an adc freestyle libre sensor, reporting symptoms of pain, swelling, and an abscess.Customer had contact with a healthcare professional and was prescribed fusidic acid topical antibiotic and hexomedine (hexamidine) topical antiseptic/disinfectant for treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Since no product has been returned, extended investigation has been performed for the reported complaint and 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 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 infection while wearing an adc freestyle libre sensor, reporting symptoms of pain, swelling, and an abscess.Customer had contact with a healthcare professional and was prescribed fusidic acid topical antibiotic and hexomedine (hexamidine) topical antiseptic/disinfectant for treatment.There was no report of death or permanent injury 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 Key8962862
MDR Text Key156556008
Report Number2954323-2019-06783
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 10/29/2019
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? No
Initial Date Manufacturer Received 08/12/2019
Initial Date FDA Received09/04/2019
Supplement Dates Manufacturer Received10/07/2019
Supplement Dates FDA Received10/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age31 YR
Patient Weight57
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