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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 Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091)
Event Date 02/18/2019
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. All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
An hcp reported a customer experienced an allergic skin reaction on day 3 of wear of the adc freestyle libre pro sensor. The customer presented with "redness and bumps" just on her right arm and self-treated with benadryl, claritin and hydrocortisone cream. A couple of days later, the redness and bumps from the right upper arm had spread and "weeping yellowish" discharge was noted. The customer had hcp contact and was administered an injection of the steroid, kenalog (dose unknown,) and was given a prescription for augmentin (amoxicillin, dose unknown) 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
An hcp reported a customer experienced an allergic skin reaction on day 3 of wear of the adc freestyle libre pro sensor. The customer presented with "redness and bumps" just on her right arm and self-treated with benadryl, claritin and hydrocortisone cream. A couple of days later, the redness and bumps from the right upper arm had spread and "weeping yellowish" discharge was noted. The customer had hcp contact and was administered an injection of the steroid, kenalog (dose unknown,) and was given a prescription for augmentin (amoxicillin, dose unknown) for treatment. 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 Key8440373
MDR Text Key139456301
Report Number2954323-2019-02333
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
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 Received03/21/2019
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2019
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: 03/21/2019 Patient Sequence Number: 1
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