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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC / UNOMEDICAL A/S MINIMED QUICK-SET INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC / UNOMEDICAL A/S MINIMED QUICK-SET INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-387A
Device Problems Failure to Deliver (2338); Obstruction of Flow (2423); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hyperglycemia (1905); Muscle Weakness (1967); Nausea (1970); Lethargy (2560)
Event Date 04/21/2021
Event Type  Injury  
Event Description
Prolonged high blood sugar; i have type 1 diabetes. I have a medtronic minimed insulin pump, model 670g. I have to order minimed quick-set infusion sets to use the pump. With the last 2 boxes that i have ordered (ordered product #mmt-387a, minimed¿ quickset ¿ 6mm cannula/32" tubing on (b)(6) 2021; ordered product #mmt-398a, minimed¿ quick-set¿ 6mm cannula/43" tubing on (b)(6) 2021), i have experienced blockages in the infusion site with 40% of the infusion sets (4 out of each box of 10). The blockages rendered the set useless, as the pump was delivering 0 insulin. I have reported the incidents to medtronic both times and received replacement infusion sets in one of the instances. I will be receiving the replacements for the second instance this week. With the replacement infusion sets that i received, one set had a blockage. Because so many of the sets don't work, in both instances i was unprepared with no sets at all and had to discontinue pump use for up to 3 days until i received the replacements. I use syringes as a backup method. Using syringes makes my blood sugar much harder to control. My blood sugar normally ranges from 90 to 140. When i only use syringes, it has been running from 150-400. The prolonged high blood sugars mean i have symptoms of lethargy, nausea, and muscle weakness. I have managed to avoid more serious illness like hospitalization or coma, but the possibility of these is much higher without a reliable insulin delivery method. An elevated a1c also contributes in the long-term to kidney disease, heart disease, and nerve damage. Fda safety report id # (b)(4).
 
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Brand NameMINIMED QUICK-SET INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC / UNOMEDICAL A/S
MDR Report Key11737165
MDR Text Key248079997
Report NumberMW5101011
Device Sequence Number1
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 04/22/2021
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-387A
Was Device Available for Evaluation? Yes
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: 04/27/2021 Patient Sequence Number: 1
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