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

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).

• Brand Name: MINIMED QUICK-SET INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC / UNOMEDICAL A/S
• MDR Report Key: 11737165
• MDR Text Key: 248079997
• Report Number: MW5101011
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MMT-387A
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 55