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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRA 2; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
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ABBOTT DIABETES CARE INC. FREESTYLE LIBRA 2; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER Back to Search Results
Device Problems Product Quality Problem (1506); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 06/22/2021
Event Type  malfunction  
Event Description
Freestyle libra 2 doesn't work.Between my father and i, we've had 3 different monitors and several different sensors that are to last for 14 days.They don't even last 24 hours.The reviews are horrible.My father paid over (b)(6) out of pocket and he's elderly.I paid (b)(6) copay.That's a lot of money to be out for a system that doesn't work.Not to mention all the others that have complained.Something needs to be looked into and shut down as abbott is making a killing on a product that doesn't work.I expect something be done for both my father and myself.I had both systems working at first so i know i did it correctly.Causes inaccurate readings.I'm not listing all.The problem is with the devise for both my dad and myself.Not to mention this is his second in less then 2 months.Plus he had a hospitalization in between because he needs to rely in taking his blood sugar levels.Fda safety report id# (b)(4).
 
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Brand Name
FREESTYLE LIBRA 2
Type of Device
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key12066793
MDR Text Key258700759
Report NumberMW5102144
Device Sequence Number1
Product Code NBW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/23/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
Patient Weight79
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