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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MINIMED QUICK SET MINIMED QUICK SET WITH SENSOR

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MEDTRONIC MINIMED MINIMED QUICK SET MINIMED QUICK SET WITH SENSOR Back to Search Results
Lot Number 5165477, 5148421
Device Problem High Test Results (2457)
Patient Problem Hypoglycemia (1912)
Event Date 08/21/2017
Event Type  Injury  
Event Description
On (b)(6) 2017: before i left work, i checked my bg, as i do everyday; i was at 102. Within an hour, and after a car crash, when the paramedics arrived, my bg was 40. On (b)(6) 2017: after two hours of being home, the paramedics arrived and my bg was 28. (an all-time-low, that's for sure). Diagnosis or reason for use: diabetes type 1. "event abated afer use stopped or dose reduced: no. Event reappeared after reintroduction: yes. ".
 
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Brand NameMINIMED QUICK SET
Type of DeviceMINIMED QUICK SET WITH SENSOR
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key6864762
MDR Text Key86278491
Report NumberMW5072145
Device Sequence Number0
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date10/01/2019
Device Lot Number5165477, 5148421
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Type of Device Usage

Patient Treatment Data
Date Received: 09/13/2017 Patient Sequence Number: 1
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