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

Model Number MMT-398A

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: 7
• 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

• Device Model Number: MMT-398A
• 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: 04/27/2021 Patient Sequence Number: 1