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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC / UNOMEDICAL A/S MEDTRONIC MINIMED MIO ADVANCE SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC / UNOMEDICAL A/S MEDTRONIC MINIMED MIO ADVANCE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problems Hyperglycemia (1905); Missed Dose (2561)
Event Date 02/21/2021
Event Type  Injury  
Event Description
Insulin not administered; could not control my blood sugar after attaching a new set; when i removed set, noticed insulin coming out at the base of the needle. This caused me to not receive my doses of insulin and my blood sugars to rise into the 300's. There appears to be a faulty connection in the clip where the tubing attaches to the metal needle that accesses the port on my body. Fda safety report id # (b)(4).
 
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Brand NameMEDTRONIC MINIMED MIO ADVANCE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC / UNOMEDICAL A/S
MDR Report Key11372250
MDR Text Key233525178
Report NumberMW5099577
Device Sequence Number2
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/21/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/23/2021
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/23/2021 Patient Sequence Number: 1
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