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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM

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ABBOTT DIABETES CARE INC FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71562-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Cellulitis (1768); Erythema (1840); Pain (1994); Swelling (2091)
Event Date 04/08/2019
Event Type  Injury  
Manufacturer Narrative
The customer's products have been requested for investigation. A follow-up report will be filed once the product is returned or additional information is obtained. The date of manufacture is unknown. All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A healthcare provider reported a patient/customer experienced an infection while wearing an adc freestyle libre sensor. The sensor had been inserted on (b)(6) 2019, but on (b)(6) 2019 the patient went to a hospital due to experiencing pain at the insertion site. The nurse instructed the patient to remove the sensor but he declined to do so; choosing to watch the site. Three days later ((b)(6) 2019), the patient returned to the hospital and the sensor was removed. Upon removal, the site was found to be ¿a little red, hot to touch, swollen arm, tension around the neck and shoulder¿. Additionally, there was a ¿white liquid¿ on the sensor tip. The patient was diagnosed with cellulitis and prescribed cefzon (cefdinir, an antibiotic). There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated. Performed a visual inspection on the returned libre pro sensor patch. No issues were observed. The sensor applicator and container were not returned. Extended investigation has also been performed for the reported complaint and determined that there was no indication that the product did not meet specification. Dhr (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and 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.
 
Event Description
A healthcare provider reported a patient/customer experienced an infection while wearing an adc freestyle libre sensor. The sensor had been inserted on (b)(6) 2019, but on (b)(6) 2019 the patient went to a hospital due to experiencing pain at the insertion site. The nurse instructed the patient to remove the sensor but he declined to do so; choosing to watch the site. Three days later ((b)(6) 2019), the patient returned to the hospital and the sensor was removed. Upon removal, the site was found to be ¿a little red, hot to touch, swollen arm, tension around the neck and shoulder¿. Additionally, there was a ¿white liquid¿ on the sensor tip. The patient was diagnosed with cellulitis and prescribed cefzon (cefdinir, an antibiotic). There was no report of death or permanent injury associated with this event.
 
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Brand NameFREESTYLE LIBRE PRO
Type of DeviceFLASH 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 Key8546888
MDR Text Key142976427
Report Number2954323-2019-03314
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P150021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71562-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/24/2019 Patient Sequence Number: 1
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