MAUDE Adverse Event Report: MEDTRONIC MINIMED INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-243AT

Device Problem Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Scar Tissue (2060); Subcutaneous Nodule (4548)

Event Date 05/01/2017

Event Type  Injury  

Event Description

Reporter calling with concerns about increasing amounts of scar tissue and "knots" that are "all over my belly" as a result of infusion set use.Reporter states that every time he removes the medtronic infusion set from his body, there is a "knot" in the spot where the infusion set was applied.He states that he has so much scar tissue now that he is having an extremely difficult time finding a good spot to use whenever he attempts to apply a new infusion set.As a result of this scar tissue, he has concerns that he is not receiving insulin that he depends on to control his blood sugar.He states he has been hyperglycemic as well as hypoglycemic as a result of this issue.Reporter states he is very careful and follows proper technique and skin preparation prior to applying his infusion sets; this is not a situation of him being careless in regards to how he uses this device.He has contacted medtronic about the problem he is having and continues to see his regular physician as well.Reporter states he really likes the medtronic pump.He finds the controls on the pump very user friendly and the device interface is easy for him to use.

• Brand Name: INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 15147879
• MDR Text Key: 297156123
• Report Number: MW5111228
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244025172
• UDI-Public: 05705244025172
• Combination Product (y/n): N
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2024
• Device Model Number: MMT-243AT
• Device Lot Number: 5350209
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC INSULIN PUMP, MMT-1780KL
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male