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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE

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FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Refill rx for freestyle libre 2 sensors. Tech filled freestyle libre sensor, and pharmacist didn't catch that it wasn't "2" and approved it as such. Patient called saying her sensor wouldn't work and brought it back in and confirmed we had dispensed the wrong product. Pt called saying her sensor wouldn't work and brought it back in and confirmed we had dispensed the wrong product. Similar names: verbal and written brand names look alike. Brand names sound alike. Similar labels / packaging. Dispensing device involved. Error reached pt; no pt harm. (b)(4).
 
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Brand NameFREESTYLE LIBRE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
MDR Report Key12878231
MDR Text Key281418834
Report NumberMW5105603
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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