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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Low Readings (2460)
Patient Problem Hyperglycemia (1905)
Event Date 03/06/2021
Event Type  Injury  
Event Description
The medtronic mini-med insulin pump serial no. (b)(4) malfunction and was reading low blood glucose, i ate and drank a juice, and the bs when from 53 mg/dl to 43 mg/dl after eating. I was in a place that i could not check my blood glucose immediately, but because i am a pharmacist, i knew that it was an error. It kept alarming until i got home and check my bs which on the contour meter was 349 mg/dl. I then decided to stop using the pump, as the pump has been constantly asking to recheck blood glucose up to 6 times per day, the sensor may stop working and you have to change the sensor after 3-4 days, and the product cannot be trusted to give you the exact values when needed. I called medtronic today (b)(6) 2021 and reported the problem and was given a case no. Of (b)(4). Will follow up tomorrow with my doctor to determine alternative therapy. Results on pump continue to decrease although food was eaten. Fda safety report id # (b)(4).
 
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Brand NameSENSOR, GLUCOSE, INVASIVE
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key11453483
MDR Text Key239167828
Report NumberMW5099892
Device Sequence Number2
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/07/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/09/2021 Patient Sequence Number: 1
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