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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE CGM; SENSOR, GLUCOSE, INVASIVE
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE CGM; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Defective Device (2588)
Patient Problem Bruise/Contusion (1754)
Event Date 02/10/2022
Event Type  Injury  
Event Description
I received a three month supply of freestyle libre sensors.Over a nine area period all six devices proved defective.As a result of repeated applications, i have what i surmise is skeletal bruising.X-rays taken awaiting results.Abbott laboratories were advised of the defects but no action was taken to assure against a repeat occurrence.Fda safety report id# (b)(4).
 
Event Description
I received a three month supply of freestyle libre sensors.Over a nine area period all six devices proved defective.As a result of repeated applications, i have what i surmise is skeletal bruising.X-rays taken awaiting results.Abbott laboratories were advised of the defects but no action was taken to assure against a repeat occurrence.Fda safety report id# (b)(4).
 
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Brand Name
FREESTYLE LIBRE CGM
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key13584389
MDR Text Key286109156
Report NumberMW5107629
Device Sequence Number2
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
Report Date 02/17/2022
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Patient Sequence Number1
Treatment
BABY ASPIRIN ; BUMETANIDE; CALCITROL ; CLOPIDOGREL ; FREESTYLE LIBRE; LAMICTAL ; LEXAPRO ; LIPITOR; LISINOPRIL ; LOW DOSE ASPIRIN; OSEMPIK; SPIRIVA; VITAMIN D VITAMIN SUPPLEMENT; XANAX
Patient Outcome(s) Other;
Patient Age71 YR
Patient SexMale
Patient Weight134 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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