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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71702-01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 04/11/2018
Event Type  Injury  
Manufacturer Narrative
The customer's products have been requested for investigation.A follow-up report will be filed once the meter is returned or additional information is obtained.The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer¿s son reported customer experienced pain and an infection while wearing an adc freestyle libre sensor.It was further reported that after three days of wear, the insertion site began to feel uncomfortable so it was removed.After removal, the insertion site was found to be notable for the presence of ¿redness, was swollen and there was a lump¿ so he self-presented to a hospital on (b)(6) 2018.Customer was given desloratadine, (an anti-histamine), mupirocin and another unspecified ¿cream¿ for topical application.Customer was contacted in follow-up for details pertaining to treatment and reported the area continued to swell so he again went to a hospital on (b)(6) 2018, where he had an ultrasound and an incision and drainage of the abscess was performed; with removal of a blood clot.There was no report of death or permanent injury associated with this event.
 
Event Description
Customer¿s son reported customer experienced pain and an infection while wearing an adc freestyle libre sensor.It was further reported that after three days of wear, the insertion site began to feel uncomfortable so it was removed.After removal, the insertion site was found to be notable for the presence of ¿redness, was swollen and there was a lump¿ so he self-presented to a hospital on (b)(6) 2018.Customer was given desloratadine, (an anti-histamine), mupirocin and another unspecified ¿cream¿ for topical application.Customer was contacted in follow-up for details pertaining to treatment and reported the area continued to swell so he again went to a hospital on (b)(6) 2018, where he had an ultrasound and an incision and drainage of the abscess was performed; with removal of a blood clot.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 and there was no indication that the product did not meet specification.A dhr (device history review) for the freestyle libre sensor kit was reviewed and the dhr showed freestyle libre sensor kit passed all tests prior to release.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 that 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.
 
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Brand Name
FREESTYLE LIBRE
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
1360 south loop road
alameda CA 94502 7001
MDR Report Key7512505
MDR Text Key108198437
Report Number2954323-2018-03633
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 02/12/2019
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 Number71702-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/17/2018
Initial Date FDA Received05/14/2018
Supplement Dates Manufacturer Received01/15/2019
Supplement Dates FDA Received02/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
Patient Weight47
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