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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. / ABBOTT LABS ABBOTT LABS FREE STYLE LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. / ABBOTT LABS ABBOTT LABS FREE STYLE LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/06/2019
Event Type  No Answer Provided  
Event Description
I have had numerous 10 and 14 day el libre sensors just fall out of my arm, the last 14 day sensor fell out after shower, i experienced with and without using the skin prep product suggested by abbott labs.The 10 day sensors were staying in after some initial problems but then abbott labs discontinued.The 1st 14 day sensor stayed in 10 days, the rest fell out, for no reason afer 1-4 days i shave my arm, clean with alcohol pad, use skin prep; then insert sensor.I allow dry time, sensors replaced by abbott labs on: (b)(6) 2019, (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019.Abbott labs keeps record which is tied to my phone # (b)(6).The (b)(6) 2019 replacement is being mailed.
 
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Brand Name
ABBOTT LABS FREE STYLE LIBRE 14 DAY SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC. / ABBOTT LABS
MDR Report Key9213701
MDR Text Key163047490
Report NumberMW5090480
Device Sequence Number3
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
ALLEGRA ; BABY ASPIRIN 81 MG; CLOPIDOGREL; FENOFIBRATE; FLUOXETINE; GABAPENTIN; GLIPIZIDE; HYDROCHLOROTHIAZIDE; IBUPROFEN ; ISOSORBIDE MONONITRATE; LOSARTAN ; METFORMIN ; METOPROLOL; MULTIVITAMIN ; OMEPRAZOLE ; ROSUVASTATIN ; VICTOZA; VITAMIN B
Patient Age49 YR
Patient Weight129
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