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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); Purulent Discharge (1812); Unspecified Infection (1930)
Event Date 12/11/2019
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 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
A family member called on behalf of a customer to report that the customer experienced a skin reaction while wearing an adc freestyle libre sensor.It was further reported the customer experienced symptoms described as ¿pus, abscess, hardened around sensor insertion site and infection.The customer, who is a healthcare professional self-treated with ceclor (cephalosporin), an oral antibiotic as treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned and 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.
 
Event Description
A family member called on behalf of a customer to report that the customer experienced a skin reaction while wearing an adc freestyle libre sensor.It was further reported the customer experienced symptoms described as ¿pus, abscess, hardened around sensor insertion site and infection.The customer, who is a healthcare professional self-treated with ceclor (cephalosporin), an oral antibiotic as treatment.There was no report of death or permanent injury associated with this event.
 
Event Description
A family member called on behalf of a customer to report that the customer experienced a skin reaction while wearing an adc freestyle libre sensor.It was further reported the customer experienced symptoms described as ¿pus, abscess, hardened around sensor insertion site and infection.The customer, who is a healthcare professional self-treated with ceclor (cephalosporin), an oral antibiotic as treatment.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Additional information: section d4 (expiration date) was updated based on investigation.Section e3 (occupation) was also updated as the complaint indicated that the customer was a physician.Sensor (b)(4) has been returned and investigated.Visual inspection was performed on the returned sensor and adhesive, no issues were observed.The sharp was not returned, however an extended investigation for this complaint (and matching serial number) was previously completed and reported in the previous submission, therefore no further investigative actions are required.No malfunction or product deficiency was identified.
 
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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 Key9492393
MDR Text Key172580638
Report Number2954323-2019-10018
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,Followup
Report Date 10/08/2020
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 Expiration Date06/30/2020
Device Model Number71940-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Initial Date Manufacturer Received 12/11/2019
Initial Date FDA Received12/19/2019
Supplement Dates Manufacturer Received01/06/2020
09/23/2020
Supplement Dates FDA Received01/27/2020
10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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