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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES FREESTYLE LIBRE SENSOR KIT 14 DAYS SENSOR, GLUCOSE, INVASIVE

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ABBOTT LABORATORIES FREESTYLE LIBRE SENSOR KIT 14 DAYS SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 191129P
Device Problems Defective Component (2292); Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2020
Event Type  malfunction  
Event Description
Pt reports that the filament is not a filament but a rigid needle - thicker and longer than normal filaments, not flexible. Fda safety report id# (b)(4).
 
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Brand NameFREESTYLE LIBRE SENSOR KIT 14 DAYS
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT LABORATORIES
MDR Report Key9744687
MDR Text Key180890312
Report NumberMW5093211
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 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Lot Number191129P
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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