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U.S. Department of Health and Human Services

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

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ABBOTT DIABETES CARE INC. FREESTYLE LIBRE SENSOR KIT 14 DAY SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 1904082
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2019
Event Type  malfunction  
Event Description
Freestyle libre sensor is not sticking 14d.
 
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Brand NameFREESTYLE LIBRE SENSOR KIT 14 DAY
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE INC.
MDR Report Key8869159
MDR Text Key153856812
Report NumberMW5088850
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 08/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Lot Number1904082
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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