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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTLE LIBRE SENSOR KIT - 14 DAY; SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABETES CARE INC. FREESTLE LIBRE SENSOR KIT - 14 DAY; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
Pt complaint that freestyle libre sensor kit only worked from (b)(6) 2021 to (b)(6) 2021.Reader said to change the sensor.Pt states the number from the sensor om000kd14y8, he also said that a similar problem last time.Pt wanted to formally express concern about this one.Mfr is doing a replacement, but since he is consistently having apparent mfg issues.He wants it documented.He does have the product available for return but mfr may be sending him a return mailer.
 
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Brand Name
FREESTLE LIBRE SENSOR KIT - 14 DAY
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key13093719
MDR Text Key282955549
Report NumberMW5106297
Device Sequence Number1
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 Pharmacist
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/27/2021
Patient Sequence Number1
Patient Age75 YR
Patient SexMale
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