MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC MINIMEN 650G; INSULIN PUMP

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hypoglycemia (1912); Seizures (2063)

Event Date 08/30/2017

Event Type  Injury  

Event Description

Reporter stated that on (b)(6), her husband changed his infusion set at 10:30 pm and went to bed.Two hours later at 12:30 am, he had a hypoglycemic seizure which made him fall out of the bed and fractured his arm.When his pump was checked, his blood sugar was below 20mg/dl.Reporter stated she gave him orange juice and continued to check his blood sugar till paramedics arrived and took him to er.He was administered 5 percent glucose iv and injections.After several hours at the hospital his blood sugar went up.Surgery was done the following day for his arm.The infusion set he switched to has a recall.Reporter stated she received a letter from medtronic stating the set was faulty and may be overdelivering insulin.

• Brand Name: MEDTRONIC MINIMEN 650G
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 6879280
• MDR Text Key: 86976164
• Report Number: MW5072216
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: MMT-1715K
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR
• Patient Weight: 88